MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT BALANCE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 511B

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Conclusion: product was not returned for analysis; however, the photographs and video provided by the customer provides clear evidence of a tma leak; therefore, the reported event is considered confirmed.A trend in affinity nt hollow fiber oxygenators (hfo) for tma leaks has been identified and a formal investigation was initiated to address this issue.The ifu contains warnings regarding leaks observed during priming and/or operation.The ifu also states: "the extracorporeal circuit must be continually monitored.Do not use the device if leaks are observed.A replacement oxygenator should be readily available during perfusion." previous discussions regarding oxygenator leaks were done with office of medical affairs, which determined the leak rate from a tma leak would not typically warrant a transfusion.Further, it is unknown why the customer chose to continue using the device for the duration of time required for 150cc to 200cc of blood to drip out.Leaks of this nature primarily lead to no patient consequence; regardless, the medical staff has to respond the each case based on the unique patient and therapy conditions.Review of risk management document and historical field performance data found the occurrence of this type of report to be rare and the overall product risk remains acceptable.Trends for issues with this product are reviewed at quarterly quality meetings.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this affinity nt oxygenator a leak was observed from the temperature monitoring port during surgery.Approximately 150cc to 200cc of blood leaked.The physician didn¿t properly calculate the volume of blood lost.1 rbc was transfused as a result of the leak.The oxygenator was replaced.The patient impact was reported as asked but unknown and there were no reported adverse patient effects.

• Brand Name: AFFINITY NT BALANCE
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12283586
• MDR Text Key: 265264712
• Report Number: 2184009-2021-00064
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K191444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2021
• Device Model Number: 511B
• Device Catalogue Number: 511B
• Device Lot Number: 13335347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/05/2021
• Date Device Manufactured: 03/25/2020
• 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): Required Intervention