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

Model Number	CB4W67R15
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
With the available information, medtronic cannot confirm or deny the root cause of this occurrence as no product has been returned to date.Medtronic's investigation is still in progress.
Event or Problem Description
Medtronic received information that after initiating extracorporeal membrane oxygenation (ecmo) support using a medtronic tubing pack, the customer observed very low patient blood pressure.After approximately seven minutes, the customer realized the red and blue labels on the tubing outside of the sterile field, did not coincide with the red blue labels on the inside of the sterile field that were connected to the arterial and venous cannula.The lines were clamped, tubing cut, and circuit re-connected the correct way.Patient blood pressure returned to normal and no adverse patient effects were reported.The product is not expected to return to medtronic for analysis.During priming of this circuit, the customer observed a leak from the 3/8 inch connector with blue tape.The customer cut the piece to replace it with another connector.While the leaking connector had blue tape present, the replacement connector did not.After the connector was replaced, priming was completed and ecmo initiated.
Additional Manufacturer Narrative
Medtronic is pursuing additional information to clarify the official cause of patient death and confirm whether or not the medtronic product event caused or contributed to the patient outcome.Conclusion of medtronic investigation: 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.The root cause for this event could not be determined.Although the root cause could not be determined, the medtronic quality engineers implemented a simplified process for the tubing pack assembly as a preventative measure.
Event or Problem Description
Medtronic received information that during a procedure, the customer observed very low patient blood pressure for approximately 7 minutes.After 7 minutes, the customer realized the red and blue labels on the tubing in the clamshell outside the sterile field, did not coincide with the red and blue labels on the inside of the sterile field.The customer clamped the tubing, re-adjusted to ensure the red/blue orientation was correct, un-clamped the tubing and resumed ecmo support.The customer indicated the patient blood pressure returned to normal.The product is not expected to return to medtronic.After several more days on ecmo support, the patient ultimately expired on (b)(6) 2016.
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: 6221811
• Report Number: 2184009-2017-00002
• Device Sequence Number: 408084
• Product Code: DTZ
• UDI-Device Identifier: 00643169602762
• UDI-Public: 00643169602762
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2017
• Device Model Number: CB4W67R15
• Device Catalogue Number: CB4W67R15
• Device Lot Number: 211403627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided; 01/13/2017
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 02/06/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1