MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS MEDTRONIC TUBING PACK; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	BB7V77R
Medical Device Problem Code	Decoupling (1145)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: medtronic cannot confirm or deny the relationship between the patient outcome and reported product issue as no product has been returned to date.Medtronic's investigation is in progress.
Event or Problem Description
Medtronic received information that after several days on extracorporeal membrane oxygenation (ecmo) support, a connection within this custom perfusion pack became disconnected.The patient received cardiopulmonary resuscitation (cpr) for approximately seven minutes while the circuit was being replaced.The customer indicated that after de-airing the circuit and replacing the connector, ecmo resumed.The patient ultimately passed away.Several attempts to obtain additional information regarding patient impact clarification, cause of death and date of death have been made and no response has been received.The product is not expected to return to medtronic.
Additional Manufacturer Narrative
Conclusion: medtronic is unable to confirm or deny the relationship between the patient outcome and reported product issue as no product has been returned to date.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Medtronic will continue to monitor for future occurrences and trends.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC TUBING PACK
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• MDR Report Key: 6236979
• Report Number: 2184009-2017-00003
• Device Sequence Number: 13649168
• Product Code: DTZ
• UDI-Device Identifier: 00643169505681
• UDI-Public: 00643169505681
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K891687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2017

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
• Operator of Device: No Information
• Device Expiration Date: 05/31/2017
• Device Model Number: BB7V77R
• Device Catalogue Number: BB7V77R
• Device Lot Number: 210725941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided; 01/30/2017; 01/30/2017
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 02/23/2017; 09/28/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention