MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I ADULT WITH SOFTLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 71000-J

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problems Death (1802); Fungal Infection (2419)

Event Date 07/14/2014

Event Type  Death  

Event Description

On (b)(6) 2014 at the (b)(6) hospital.In (b)(6) it was reported that the color of the gas indicator seal on the sterilized package of the hmo 71000-j quadrox-i oxygenator from lot number 70096734 was brown and green which the user noticed as not typical.The oxygenator was used for cardiac surgery along with other devices on (b)(6) 2014 and then used again for surgery on (b)(6) 2014.The patient developed an aspergillus infection of the ascending aorta after the surgery and subsequently expired.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device (b)(4).The sample was discarded by the user and hence no laboratory evaluation could be performed.A review of the production records for the specific product lot was performed and no abnormalities were found.The certificate of eto (ethylene oxide) sterilization issued by the sterilization contractor was reviewed and all parameters were found to be in compliance with the specifications.The eo gas label is a qualitative indicator whose color change only indicates that the product has been exposed to eo gas.It is not a sterility claim for the product and it is not used for the release of the sterilized product.The sterile product is released on the basis of the certificate of processing from the sterilization contractor, in accordance to the validated sterilization process.(b)(4).

• Brand Name: QUADROX-I ADULT WITH SOFTLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4945343
• MDR Text Key: 6037781
• Report Number: 8010762-2015-00475
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2015
• Device Model Number: HMO 71000-J
• Device Catalogue Number: 70104.8762
• Device Lot Number: 70096734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/06/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2014
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death