MAUDE Adverse Event Report: PERFUSION SYSTEMS PERFUSION ADAPTER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	10007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Ischemia (1942); Vascular System (Circulation), Impaired (2572)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: visual inspection shows a piece of the broke device was returned installed on a connector.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of a dlp perfusion adapter when the patient (on full va-ecmo support) was been brought from intensive care to the operating room the connector broke.The break partially stopped blood circulation to the patient for approximately 2 minutes.The adapter had been in place for 4 days.There was no leak as air was aspirated through the broken connector.It is unknown if the device was replaced.
Additional Manufacturer Narrative
Conclusion; complaint is confirmed for a broken perfusion adapter.It is unknown what may have caused this occurrence, however there is the possibility that this was caused by excessive force being applied during use.Correction: patient code updated if information is provided in the future, a supplemental report will be issued.

• Brand Name: PERFUSION ADAPTER
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8178156
• Report Number: 2184009-2018-00047
• Device Sequence Number: 1960075
• Product Code: DWF
• UDI-Device Identifier: 00613994756701
• UDI-Public: 00613994756701
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 10007
• Device Catalogue Number: 10007
• Device Lot Number: 2018060944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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: Hospitalization
• Patient Age: 56 YR
• Patient Weight: 80