URGENT FIELD SAFETY NOTICE

Transcription

1 URGENT FIELD SAFETY NOTICE This Field Safety Notice calls attention to a safety aspect of the Terumo Extracorporeal Tubing Sets involving the LN130B Over-pressure Safety Valve or the LH130 Single, Sterile Over-pressure Safety Valve Attention: Chief of Perfusion; Director of Operating Room Services; Director of Biomedical Services; Risk Management Affected Product: LH130 Single, Sterile Over-pressure Safety Valve (often referred to as Vent Valve), LN130B Non-Sterile Over-pressure Safety Valve, Extracorporeal Tubing Set containing the Over-pressure Safety Valve Action: Advisory WHAT TO DO NEXT REASON FOR CORRECTION This Field Safety Notice calls attention to a situation that may arise with the LN130B over-pressure safety valve (OPS valve) within your Terumo Extracorporeal Tubing Set or the LH130 single, sterile OPS valve, and recommends how to check to ensure the duckbill valve within the OPS valve is patent and allows flow through the valve. The LN130B or LH130 OPS valves are to prevent reversal of blood flow and the prevention of air embolism as well as limit excessive negative and positive pressure in the vent catheter. The OPS valve allows for flow in only one direction (from the catheter in the heart to the cardiotomy reservoir). Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the OPS valve. Terumo CVS has received no reports of patient injury due to this issue. Review this Urgent Field Safety Notice and follow the instructions in the Recommended Action section of this letter. Note that Terumo CVS is not requesting removal or return of product as a result of this Field Safety Notice activity. If you have questions, contact your local Terumo representative. POTENTIAL HAZARD No flow through the duckbill valve within the OPS valve would prevent the ability to vent blood from the left ventricle, potentially resulting in distension of the ventricle. If the distension is prolonged, this may result in severe ventricular dysfunction. RECOMMENDED ACTIONS Note: This is an advisory Field Safety Notice. Terumo CVS is not requesting removal or return of product as a result of this activity. Terumo Cardiovascular Systems/ Terumo Europe N.V. Page 1 of 13

2 Affected Product: LN130B and LH130 OPS Valves Terumo CVS recommends that the customer test the valve in the tubing pack prior to use to ensure flow through the valve. 1. A member of the surgical team shall place the sterile end of the tubing with LN130B or LH130 OPS valve in a basin of fluid on the sterile field and initiate pump flow to ensure flow through the valve. 2. If no fluid flow is evident through the duckbill valve after the test described above, maintain the tubing in the basin and place gloved fingers over the positive and negative umbrella relief valves (see diagram below). Turn on the roller pump at approximately 500 ml/minute and allow up to 30 seconds to create negative pressure on the duckbill valve to initiate fluid flow through the device. Once the duckbill is opened, it will operate as intended. Turn off roller pump. 3. If flow is still not observed, then we recommend removing the valve and replacing it with a single, sterile OPS valve. Please return the defective LN130B or LH130 OPS valve to Terumo. 4. If you do not have a single, sterile OPS valve available, open a new Extracorporeal Tubing Set and use the line and OPS valve from it. AFFECTED POPULATION Any patient who is exposed to a Extracorporeal Tubing Set with LN130B OPS valve or a LH130 single, sterile OPS valve. AFFECTED PRODUCT Catalog Number Product Description Lot Number Range LH130 LN130B Single, Sterile OPS (Vent) Valve Non sterile OPS (Vent) Valve Lot # RK11, RK20, RL02, RL08, RM20, RP08, TE27, TF08, TF14, TF21, TH06, TH16, TL21, TP14, UA11, UC08, UD14, UD28, UE05, UE18, UF09, UG06, UL12, UM10, VA02, VC06 Lot # RL15, RL22, RM27, RP01, RP22, TA12, TE17, TE20, TE22, TE23, TE24, TE25, TF01, TF04, TF06, TF07, TF08, TF15, TF18, TF19, TF20, TF21, TF30, TG01, TG04, TG05, TG08, TG12, TG15, TG16, TG17, TG19, TG22, TG23, TG24, TG25, TH06, TH07, TH08, TH09, TH10, TH13, TH15, TH17, TH31, TK03, TK04, TK06, TK07, TK10, TK12, TK14, TK17, TK18, TK24, TL23, TL25, TL28, TM01, TM05, TM07, TM09, TM23, TM26, TM28, TN02, TN05, TN19, TN23, TP01, UA04, Terumo Cardiovascular Systems/Terumo Europe N.V. Page 2 of 13

3 Affected Product: LN130B and LH130 OPS Valves CX AU038X Extracorporeal Tubing Set CX AU100X Extracorporeal Tubing Set CX AU101X Extracorporeal Tubing Set till CX AU102X Extracorporeal Tubing Set CX BE062X Extracorporeal Tubing Set till CX BE063X Extracorporeal Tubing Set till CX BE066X Extracorporeal Tubing Set till CX BE068X Extracorporeal Tubing Set till CX BE069X Extracorporeal Tubing Set till CX BE093X Extracorporeal Tubing Set till CX BE094X Extracorporeal Tubing Set CX BL040X Extracorporeal Tubing Set till CX BL047X Extracorporeal Tubing Set till CX BL053X Extracorporeal Tubing Set till CX CH034X Extracorporeal Tubing Set till CX CH049X Extracorporeal Tubing Set till CX CH062X Extracorporeal Tubing Set till CX CH071X Extracorporeal Tubing Set CX CH088X Extracorporeal Tubing Set CX CH094X Extracorporeal Tubing Set till CX CH096X Extracorporeal Tubing Set UC01, UC29, UD07, UD21, UD28, UE04, UF23, UF31, UG20, UH18, UK29, UL12, UL19, UL26, UM17, UM24, UN28, UP12, VC13, VD20, VE03, VE24, VF15 Terumo Cardiovascular Systems/Terumo Europe N.V. Page 3 of 13

4 Affected Product: LN130B and LH130 OPS Valves CX CH102X Extracorporeal Tubing Set till CX CH105X Extracorporeal Tubing Set till CX CR014 Extracorporeal Tubing Set CX CY005 Extracorporeal Tubing Set till CX CY006 Extracorporeal Tubing Set till CX DB05 Extracorporeal Tubing Set CX DB080 Extracorporeal Tubing Set till CX DB317X Extracorporeal Tubing Set till CX DB318 Extracorporeal Tubing Set CX DB319 Extracorporeal Tubing Set CX DB320 Extracorporeal Tubing Set CX DB321 Extracorporeal Tubing Set till CX DB329 Extracorporeal Tubing Set till CX DB334X Extracorporeal Tubing Set CX DB351X Extracorporeal Tubing Set till CX DB379X Extracorporeal Tubing Set till CX DB401X Extracorporeal Tubing Set CX DB407X Extracorporeal Tubing Set CX DB408X Extracorporeal Tubing Set CX DB409X Extracorporeal Tubing Set CX DB421X Extracorporeal Tubing Set till CX DB331X Extracorporeal Tubing Set till CX DB336 Extracorporeal Tubing Set Terumo Cardiovascular Systems/Terumo Europe N.V. Page 4 of 13

5 Affected Product: LN130B and LH130 OPS Valves CX DB337 Extracorporeal Tubing Set CX DB338 Extracorporeal Tubing Set CX DB387X Extracorporeal Tubing Set CX DB388X Extracorporeal Tubing Set CX DB404X Extracorporeal Tubing Set CX DB421X Extracorporeal Tubing Set till CX DB459X Extracorporeal Tubing Set CX DB462 Extracorporeal Tubing Set CX DB463 Extracorporeal Tubing Set CX DB464 Extracorporeal Tubing Set till CX DB466 Extracorporeal Tubing Set till CX DB474X Extracorporeal Tubing Set CX DB475X Extracorporeal Tubing Set CX DB478 Extracorporeal Tubing Set CX DB481X Extracorporeal Tubing Set CX DB483X Extracorporeal Tubing Set CX DB484X Extracorporeal Tubing Set CX DB497X Extracorporeal Tubing Set till CX DB524 Extracorporeal Tubing Set till CX DK043 Extracorporeal Tubing Set till CX DK068 Extracorporeal Tubing Set till CX DK086 Extracorporeal Tubing Set CX DK087 Extracorporeal Tubing Set till Terumo Cardiovascular Systems/Terumo Europe N.V. Page 5 of 13

6 Affected Product: LN130B and LH130 OPS Valves CX DK098 Extracorporeal Tubing Set till CX DK099 Extracorporeal Tubing Set till CX DK102 Extracorporeal Tubing Set till CX DK103 Extracorporeal Tubing Set CX DK107 Extracorporeal Tubing Set CX FAC01 Extracorporeal Tubing Set till CX FAC68 Extracorporeal Tubing Set till CX FR100 Extracorporeal Tubing Set till CX FR169 Extracorporeal Tubing Set till CX FR204X Extracorporeal Tubing Set till CX FR221 Extracorporeal Tubing Set till CX FR222 Extracorporeal Tubing Set till CX GE092X Extracorporeal Tubing Set till CX GE101 Extracorporeal Tubing Set till CX GE115X Extracorporeal Tubing Set CX GE134X Extracorporeal Tubing Set till CX GE136 Extracorporeal Tubing Set till CX GE135 Extracorporeal Tubing Set till CX GE155 Extracorporeal Tubing Set CX GE157 Extracorporeal Tubing Set till CX GE157X Extracorporeal Tubing Set till CX GE166X Extracorporeal Tubing Set till CX GE173X Extracorporeal Tubing Set till Terumo Cardiovascular Systems/Terumo Europe N.V. Page 6 of 13

7 Affected Product: LN130B and LH130 OPS Valves CX GE180 Extracorporeal Tubing Set till CX GE181X Extracorporeal Tubing Set till CX GE193 Extracorporeal Tubing Set till CX GE195X Extracorporeal Tubing Set till CX GE204X Extracorporeal Tubing Set till CX GE211X Extracorporeal Tubing Set till CX GE216X Extracorporeal Tubing Set CX GE218 Extracorporeal Tubing Set till CX GG005 Extracorporeal Tubing Set till CX GG006 Extracorporeal Tubing Set till CX GG009 Extracorporeal Tubing Set till CX GG012 Extracorporeal Tubing Set till CX GG016 Extracorporeal Tubing Set till CX GG038 Extracorporeal Tubing Set till CX GG039 Extracorporeal Tubing Set till CX GG041 Extracorporeal Tubing Set CX GG042 Extracorporeal Tubing Set CX GG045 Extracorporeal Tubing Set CX GG046 Extracorporeal Tubing Set CX IC002 Extracorporeal Tubing Set CX IS019 Extracorporeal Tubing Set till CX IS021 Extracorporeal Tubing Set till CX IS022 Extracorporeal Tubing Set till Terumo Cardiovascular Systems/Terumo Europe N.V. Page 7 of 13

8 Affected Product: LN130B and LH130 OPS Valves CX IS039 Extracorporeal Tubing Set till CX IS041 Extracorporeal Tubing Set till CX IS055 Extracorporeal Tubing Set till CX IS057 Extracorporeal Tubing Set till CX IS061 Extracorporeal Tubing Set CX IS062 Extracorporeal Tubing Set till CX IS071 Extracorporeal Tubing Set till CX IS082 Extracorporeal Tubing Set till CX IS083 Extracorporeal Tubing Set CX IS088X Extracorporeal Tubing Set CX IS089X Extracorporeal Tubing Set CX IT090X Extracorporeal Tubing Set till CX IT095X Extracorporeal Tubing Set till CX IT096X Extracorporeal Tubing Set till CX IT139X Extracorporeal Tubing Set till CX IT160X Extracorporeal Tubing Set till CX IT223X Extracorporeal Tubing Set till CX IT226X Extracorporeal Tubing Set till CX IT228X Extracorporeal Tubing Set till CX IT246X Extracorporeal Tubing Set till CX IT254X Extracorporeal Tubing Set till CX IT259X Extracorporeal Tubing Set till CX IT290X Extracorporeal Tubing Set till Terumo Cardiovascular Systems/Terumo Europe N.V. Page 8 of 13

9 Affected Product: LN130B and LH130 OPS Valves CX IT291X Extracorporeal Tubing Set till CX IT292X Extracorporeal Tubing Set till CX IT304X Extracorporeal Tubing Set CX IT304X Extracorporeal Tubing Set till CX IT305X Extracorporeal Tubing Set till CX IT306 Extracorporeal Tubing Set till CX IT314X Extracorporeal Tubing Set CX NG002 Extracorporeal Tubing Set CX PL083 Extracorporeal Tubing Set till CX QE12 Extracorporeal Tubing Set till CX QE4 Extracorporeal Tubing Set till CX ROCA Extracorporeal Tubing Set till CX RU046 Extracorporeal Tubing Set till CX RU075 Extracorporeal Tubing Set CX RU100 Extracorporeal Tubing Set till CX RU100X Extracorporeal Tubing Set till CX RU101X Extracorporeal Tubing Set till CX RU103 Extracorporeal Tubing Set till CX RU103X Extracorporeal Tubing Set till CX RU124 Extracorporeal Tubing Set till CX RU125X Extracorporeal Tubing Set till CX SA021X Extracorporeal Tubing Set CX SA022X Extracorporeal Tubing Set Terumo Cardiovascular Systems/Terumo Europe N.V. Page 9 of 13

10 Affected Product: LN130B and LH130 OPS Valves CX SA024X Extracorporeal Tubing Set CX SA030X Extracorporeal Tubing Set CX SA039X Extracorporeal Tubing Set CX SE013 Extracorporeal Tubing Set till CX SE030 Extracorporeal Tubing Set CX SE037 Extracorporeal Tubing Set CX SL009X Extracorporeal Tubing Set till CX SL017X Extracorporeal Tubing Set till CX SP022 Extracorporeal Tubing Set till CX SP034XC Extracorporeal Tubing Set till CX SP049X Extracorporeal Tubing Set till CX SP054A Extracorporeal Tubing Set till CX SP054B Extracorporeal Tubing Set till CX SP064 Extracorporeal Tubing Set till CX SP066XA Extracorporeal Tubing Set till CX SP066XB Extracorporeal Tubing Set till CX SP066XC Extracorporeal Tubing Set till CX SP070 Extracorporeal Tubing Set till CX SP076A Extracorporeal Tubing Set till CX SP076B Extracorporeal Tubing Set till CX SP079 Extracorporeal Tubing Set till CX SP091 Extracorporeal Tubing Set till CX SV055 Extracorporeal Tubing Set till Terumo Cardiovascular Systems/Terumo Europe N.V. Page 10 of 13

11 Affected Product: LN130B and LH130 OPS Valves CX SV056 Extracorporeal Tubing Set till CX SV059 Extracorporeal Tubing Set till CX SV065 Extracorporeal Tubing Set till CX SV072 Extracorporeal Tubing Set CX SV073 Extracorporeal Tubing Set till CX TES014 Extracorporeal Tubing Set till CX UK224 Extracorporeal Tubing Set till CX UK325 Extracorporeal Tubing Set till CX UK343 Extracorporeal Tubing Set till CX UK352 Extracorporeal Tubing Set till CX UK371 Extracorporeal Tubing Set till CX UK437 Extracorporeal Tubing Set till CX UK440 Extracorporeal Tubing Set CX UK448 Extracorporeal Tubing Set till CX UK460 Extracorporeal Tubing Set CX UK467 Extracorporeal Tubing Set CX UK484 Extracorporeal Tubing Set till CX UK486 Extracorporeal Tubing Set CX UK487 Extracorporeal Tubing Set CX UK488 Extracorporeal Tubing Set CUSTOMER INSTRUCTIONS Review this Field Safety Notice and the Recommended Actions. Assure that all users receive notice of this issue. Confirm receipt of this Field Safety Notice by ing or faxing the attached Customer Response Form to the address or fax number indicated on the form. Terumo Cardiovascular Systems/Terumo Europe N.V. Page 11 of 13

12 Affected Product: LN130B and LH130 OPS Valves Test the OPS valve for flow prior to going on cardiopulmonary bypass by using the instructions provided in this letter. To return defective OPS valves, follow your complaint reporting protocol and contact Terumo. QUESTIONS? We encourage you to contact your local Terumo sales organization with any questions or concerns. REPORTING Any adverse event experienced with the use of this product, and/or quality problems shall immediately be reported to your local Terumo sales organization. We confirm that this Field Safety Notice has also been notified to your national Competent Authority. Organisation (to be completed by the sales or dealer) Contact name (function) Contact phone, mobile, Terumo Cardiovascular Systems/Terumo Europe N.V. Page 12 of 13

13 Affected Product: LN130B and LH130 OPS Valves FIELD SAFETY NOTICE - CUSTOMER REPLY FORM Affected Product: LH130 Single, Sterile Over-pressure Safety Valve (often referred to as Vent Valve), LN130B Non-Sterile Over-pressure Safety Valve, Extracorporeal Tubing Set containing the Over-pressure Safety Valve Action: Advisory Please complete, sign and or fax this back: To: /Telefax: Client number Hospital Name City Country Our records indicate that you have received devices from the affected population. Catalog Number Product Description Lot number By completion and return of this form, I am confirming receipt, reading and acting on this Field Safety Notice. Person Responding [Please Print] Title Phone Number Signature Date FSN1702A [EN] Terumo Cardiovascular Systems/Terumo Europe N.V. Page 13 of 13

14 FSCA ANNEX I Involved lot numbers for OPS Valve single use, sterile (LH130) and OPS valve non sterile (LN130B) Catalogue number Lot number Manufacturing date Expiry date LH130 RK LH130 RK LH130 RL LH130 RL LH130 RM LH130 RP LH130 TE LH130 TF LH130 TF LH130 TF LH130 TH LH130 TH LH130 TL LH130 TP LH130 UA LH130 UC LH130 UD LH130 UD LH130 UE LH130 UE LH130 UF LH130 UG LH130 UL LH130 UM LH130 VA LH130 VC

15 Catalogue number Lot number Manufacturing date Expiry date LN130B RL LN130B RL LN130B RM LN130B RP LN130B RP LN130B TA LN130B TE LN130B TE LN130B TE LN130B TE LN130B TE LN130B TE LN130B TF LN130B TF LN130B TF LN130B TF LN130B TF LN130B TF LN130B TF LN130B TF LN130B TF LN130B TF LN130B TF LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TG LN130B TH LN130B TH LN130B TH LN130B TH LN130B TH LN130B TH LN130B TH LN130B TH LN130B TH

16 Catalogue number Lot number Manufacturing date Expiry date LN130B TK LN130B TK LN130B TK LN130B TK LN130B TK LN130B TK LN130B TK LN130B TK LN130B TK LN130B TK LN130B TL LN130B TL LN130B TL LN130B TM LN130B TM LN130B TM LN130B TM LN130B TM LN130B TM LN130B TM LN130B TN LN130B TN LN130B TN LN130B TN LN130B TP LN130B UA LN130B UC LN130B UC LN130B UD LN130B UD LN130B UD LN130B UE LN130B UF LN130B UF LN130B UG LN130B UH LN130B UK LN130B UL LN130B UL LN130B UL LN130B UM LN130B UM LN130B UN LN130B UP LN130B VC LN130B VD

17 Catalogue number Lot number Manufacturing date Expiry date LN130B VE LN130B VE LN130B VF

18 FSCA ANNEX II Involved lot numbers for Terumo Extracorporeal Sets containing OPS valve (LN130B) Catalogue number Lot number range CX AU038X CX AU100X CX AU101X CX AU102X CX BE062X CX BE063X CX BE066X CX BE068X CX BE069X CX BE093X CX BE094X CX BL040X CX BL047X CX BL053X CX CH034X CX CH049X CX CH062X CX CH071X CX CH088X CX CH094X CX CH096X CX CH102X CX CH105X CX CR CX CY CX CY CX DB CX DB CX DB317X CX DB CX DB CX DB CX DB CX DB CX DB334X CX DB351X CX DB379X CX DB401X CX DB407X CX DB408X CX DB409X CX DB421X

19 Catalogue number Lot number range CX DB331X CX DB CX DB CX DB CX DB387X CX DB388X CX DB404X CX DB421X CX DB459X CX DB CX DB CX DB CX DB CX DB474X CX DB475X CX DB CX DB481X CX DB483X CX DB484X CX DB497X CX DB CX DK CX DK CX DK CX DK CX DK CX DK CX DK CX DK CX DK CX FAC CX FAC CX FR CX FR CX FR CX FR204X CX FR CX FR CX GE092X CX GE CX GE115X CX GE134X CX GE CX GE CX GE CX GE

20 Catalogue number Lot number range CX GE157X CX GE166X CX GE173X CX GE CX GE181X CX GE CX GE195X CX GE204X CX GE211X CX GE216X CX GE CX GG CX GG CX GG CX GG CX GG CX GG CX GG CX GG CX GG CX GG CX GG CX IC CX IS CX IS CX IS CX IS CX IS CX IS CX IS CX IS CX IS CX IS CX IS CX IS CX IS088X CX IS089X CX IT090X CX IT095X CX IT096X CX IT139X CX IT160X CX IT223X CX IT226X CX IT228X CX IT246X

21 Catalogue number Lot number range CX IT254X CX IT259X CX IT290X CX IT291X CX IT292X CX IT304X CX IT305X CX IT CX IT314X CX NG CX PL CX QE CX QE CX ROCA CX RU CX RU CX RU CX RU100X CX RU101X CX RU CX RU103X CX RU CX RU125X CX SA021X CX SA022X CX SA024X CX SA030X CX SA039X CX SE CX SE CX SE CX SL009X CX SL017X CX SP CX SP034XC CX SP049X CX SP054A CX SP054B CX SP CX SP066XA CX SP066XB CX SP066XC CX SP CX SP076A CX SP076B CX SP

22 Catalogue number Lot number range CX SP CX SV CX SV CX SV CX SV CX SV CX SV CX TES CX UK CX UK CX UK CX UK CX UK CX UK CX UK CX UK CX UK CX UK CX UK CX UK CX UK CX UK

23 SAFETY NOTICE This Safety Notice calls attention to a safety aspect of the Terumo Extracorporeal Tubing Sets involving the LN130B Over-pressure Safety Valve Attention: Chief of Perfusion; Director of Operating Room Services; Director of Biomedical Services; Risk Management Affected Product: Extracorporeal Tubing Set containing the Over-pressure Safety Valve Action: Advisory REASON FOR CORRECTION This Safety Notice calls attention to a situation that may arise with the LN130B over-pressure safety valve (OPS valve) within your Terumo Extracorporeal Tubing Set and recommends how to check to ensure the duckbill valve within the OPS valve is patent and allows flow through the valve. The valves are to prevent reversal of blood flow and the prevention of air embolism as well as limit excessive negative and positive pressure in the vent catheter. The OPS valve allows for flow in only one direction (from the catheter in the heart to the cardiotomy reservoir). WHAT TO DO NEXT Review this Safety Notice and follow the instructions in the Recommended Action section of this letter. If you have questions, contact your local Terumo representative. Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the OPS valve. Terumo CVS has received no reports of patient injury due to this issue. POTENTIAL HAZARD No flow through the duckbill valve within the OPS valve would prevent the ability to vent blood from the left ventricle, potentially resulting in distension of the ventricle. If the distension is prolonged, this may result in severe ventricular dysfunction. Terumo Cardiovascular Systems/ Terumo Europe N.V. Page 1 of 2 Safety Notice

24 RECOMMENDED ACTIONS Terumo CVS recommends that the customer test the valve in the tubing pack prior to use to ensure flow through the valve. 1. A member of the surgical team shall place the sterile end of the tubing with OPS valve in a basin of fluid on the sterile field and initiate pump flow to ensure flow through the valve. 2. If no fluid flow is evident through the duckbill valve after the test described above, maintain the tubing in the basin and place gloved fingers over the positive and negative umbrella relief valves (see diagram below). Turn on the roller pump at approximately 500 ml/minute and allow up to 30 seconds to create negative pressure on the duckbill valve to initiate fluid flow through the device. Once the duckbill is opened, it will operate as intended. Turn off roller pump. 3. If flow is still not observed, then we recommend removing the valve and replacing it with a single, sterile OPS valve. Please return the defective OPS valve to Terumo. 4. If you do not have a single, sterile OPS valve available, open a new Extracorporeal Tubing Set and use the line and OPS valve from it. CUSTOMER INSTRUCTIONS Review this Safety Notice and the Recommended Actions. Assure that all users receive notice of this issue. Test the OPS valve for flow prior to going on cardiopulmonary bypass by using the instructions provided in this letter. To return defective OPS valves, follow your complaint reporting protocol and contact Terumo. QUESTIONS? We encourage you to contact your local Terumo sales organization with any questions or concerns. REPORTING Any adverse event experienced with the use of this product, and/or quality problems shall immediately be reported to your local Terumo sales organization. Terumo Cardiovascular Systems/Terumo Europe N.V. Page 2 of 2 Safety Notice