Carefusion UK Jays Close The Crescent Basingstoke RG22 4BS United Kingdom Name: Oxygen Care Ltd Address: 2 Holfeld Business Park, Kilmacanogue, Co. Wicklow, Ireland URGENT FIELD SAFETY NOTICE - UPDATE Product Name: AVEA ventilators Product Reference: All AVEA models Serial Numbers: All (See attached list in Appendix 2) FSCA Identifier: RES2013-AVEA-01 Date: 7 th October 2013 Type of Action: Field Safety Notice Dear Mr/Mrs I write following my letter dated 18 th September 2013 to inform you that the Field Safety Notice issued by CareFusion has been updated. Please find below the changes highlighted in green. Product Name: AVEA ventilator all models CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error. The published volume accuracy specification of the neonatal hotwire flow sensor is +/- 1ml + 10%. PROBLEM AND AFFECTED DEVICES ISSUE: AVEA ventilators may experience the underreporting of tidal volume if used in conjunction with the neonatal hotwire flow sensor, CareFusion part number 16465. This error is due to the barometric pressure sensor compensation. Clinically significant changes in barometric pressure are generally seen at altitudes greater than 5,000 feet above sea level (ASL). While all AVEA ventilators fall under this voluntary Field Safety Corrective Action, hospitals in locations at high elevations (higher than 1524 meters or 5000 feet above sea level) that are using the AVEA ventilator in the neonatal patient care setting are at greatest risk of this error. Single patient use VarFlex sensors are not affected by this corrective action and will compensate for changes to atmospheric barometric pressure. The adult and pediatric patient setting are not affected by this issue.
POTENTIAL RISK: In cases where a patient is ventilated at an altitude of equal or greater than 1,524 meters ASL the ventilator may under report the delivery of tidal volume. The degree of which is based upon the altitude at the location of use. For reference: The measurement error at 1,220 meters ASL (approximately 681 mmhg) would be less than 10% and the error at 1,829 meters ASL would be approximately 16-19%. ACTIONS TO BE TAKEN BY CAREFUSION: CareFusion has initiated a project to develop a new version of software that will resolve this issue. ACTION TO BE TAKEN BY THE CUSTOMER CareFusion does not require the return of your devices. Once this software is available it must be installed on all AVEA ventilators. If the location of your AVEA ventilator(s) is above 1,524 meters ASL, and you are using the AVEA in the neonatal patient setting, customers are asked to take one of the following actions. o AVEA Comprehensive: Continue the use of your AVEA Comprehensive ventilator with the use of a VarFlex single patient use flow sensor, CareFusion part number 50000-40038 (10 pack). o AVEA Standard: Discontinue the use of your AVEA Standard ventilator in the neonatal patient setting. If the location of your hospital is located at altitude above 1,524 meters ASL a customer support representative will contact you to arrange for a suitable alternative if necessary. If the location of your hospital is below 1,524 meters, or the ventilator is exclusively used in the adult and/or pediatric patient setting, no action is necessary other than to perform the necessary software update when made available. Please promptly return the enclosed response card (Appendix 2) to expedite the correction process and acknowledge receipt of this notification. The US Food and Drug Administration (FDA) has been notified of this action. Please use the chart provided below for questions and support. CareFusion Contact Contact Information Areas of Support CareFusion Technical +49 931 4972 393 Recall Related Support Support.CC.EU@carefusion.com Questions CareFusion Business Partner Oxygen Care Ltd 2 Holfeld Business Park, Kilmacanogue, Co. Wicklow, Ireland Recall Related Questions Please promptly return the enclosed Response Card to expedite the correction process and acknowledge receipt of this Notification. We appreciate your cooperation and we recognize the inconvenience this may cause your facility. Thank you for your support on this important matter.
Sincerely, Mirela Boureanu CareFusion QRA Manager UK and Ireland Enclosed: List of affected units, customer response card
Appendix 1: List of affected part and serial numbers PART NUMBER CONFIGURATION BASE MODEL SHIP DATE TO OXYGEN CARE LTD CLEAN SN PN SN 17000-09 AVEA COMP CONF 10/09/2003 ADV02124 1700ADV02124 17000-09 AVEA COMP 27/11/2002 ACV01721 ACECACV01721 17001-13 AVEA STD 22/04/2003 ADV01605 ASHOADV01605 17001-13 AVEA STD 22/04/2003 ADV01624 ASHOADV01624 17001-13 AVEA STD 22/04/2003 ADV01648 ASHOADV01648 17001-13 AVEA STD 22/04/2003 ADV01653 ASHOADV01653 17001-13 AVEA STD 22/04/2003 ADV01669 ASHOADV01669 17000-13 AVEA COMP 23/04/2003 ADV01718 ACECADV01718 17210-09 AVEA COMP 16/12/2003 ADV05150 1721ADV05150 17210-09 AVEA COMP 16/12/2003 ADV06110 1721ADV06110 17210-09 AVEA COMP 16/12/2003 ADV06113 1721ADV06113 R17212-09 AVEA STD W/COMP CONFIG 20/05/2005 ADV06218 R172ADV06218 17210-09 AVEA COMP 15/10/2004 AEV01548 1721AEV01548 17210-09 AVEA COMP 08/10/2004 AEV01644 1721AEV01644 17210-09 AVEA COMP 08/10/2004 AEV01826 1721AEV01826 17210-09 AVEA COMP 08/10/2004 AEV01827 1721AEV01827 17210-09 AVEA COMP 15/10/2004 AEV01927 1721AEV01927 17210-09 AVEA COMP 08/10/2004 AEV01992 1721AEV01992 17210-09 AVEA COMP 08/10/2004 AEV02218 1721AEV02218 17210-09 AVEA COMP 08/10/2004 AEV02224 1721AEV02224 17210-09 AVEA COMP 08/10/2004 AEV02238 1721AEV02238 17213-09 AVEA PLUS 08/12/2005 AFV02316 1721AFV02316 17213-09 AVEA PLUS 08/12/2005 AFV02457 1721AFV02457 17213-09 AVEA PLUS 08/12/2005 AFV02503 1721AFV02503 17213-09 AVEA PLUS 08/12/2005 AFV02509 1721AFV02509 17311-09 AVEA STD 25/11/2009 AKV02584 1731AKV02584 17310-09 AVEA COMP 25/11/2009 AKV04415 1731AKV04415 17310-09 AVEA COMP 25/11/2009 AKV04416 1731AKV04416 17310-09 AVEA COMP 25/11/2009 AKV04417 1731AKV04417 17310-09 AVEA COMP 25/11/2009 AKV04418 1731AKV04418 17310-09 AVEA COMP 25/11/2009 AKV04419 1731AKV04419 17310-09 AVEA COMP 25/11/2009 AKV04420 1731AKV04420 17310-09 AVEA COMP 25/11/2009 AKV04421 1731AKV04421 17311-09 AVEA STD 25/11/2009 AKV04422 1731AKV04422 17311-09 AVEA STD 25/11/2009 AKV04423 1731AKV04423 Page 4 of 7
17311-09 AVEA STD 25/11/2009 AKV04424 1731AKV04424 17311-09 AVEA STD 25/11/2009 AKV04425 1731AKV04425 17311-09 AVEA STD 25/11/2009 AKV04426 1731AKV04426 17311-09 AVEA STD 25/11/2009 AKV04427 1731AKV04427 17311-09 AVEA STD 25/11/2009 AKV04428 1731AKV04428 17311-09 AVEA STD 01/04/2010 BAV04244 1731BAV04244 17311-09 AVEA STD 01/04/2010 BAV04249 1731BAV04249 17311-09 AVEA STD 01/04/2010 BAV04250 1731BAV04250 Page 5 of 7
Appendix 2 Business Partner Response Card UPDATE - FIELD SAFETY NOTICE AVEA Ventilators Acknowledgment and Verification Form Product Name: Product Reference: FSCA Identifier: AVEA ventilators All AVEA models RES2013-AVEA-01 Name of Business Partner Organization Business Partner Address Name of Business Partner Correspondent Telephone number Email address Signature Date I have read and understand the contents of this Field Safety Notice and confirm that all affected medical equipment within my area of responsibility has been checked, and Software will be upgraded as required. I have completed the enclosed table to reflect those devices, that cannot be upgraded (not found or scrapped). Page 6 of 7
Equipment Country Distribution Table: Model Number Serial Number Affected and will be done Other (not found or scrapped) Note: If more space is needed for the above table please attach a separate document. Please return this form to: Miss Mirela Boureanu Address: Carefusion UK, Jays Close, The Crescent, Basingstoke, RG22 4BS or By email: mirela.boureanu@carefusion.com (Return of your product is not necessary) For further questions please call CareFusion Technical Support +49 931 4972 393 Page 7 of 7