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

Model Number 10007

Device Problem Break (1069)

Patient Problems Ischemia (1942); Vascular System (Circulation), Impaired (2572)

Event Date 12/03/2018

Event Type  Injury  

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 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.

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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8178156
• MDR Text Key: 130769032
• Report Number: 2184009-2018-00047
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00613994756701
• UDI-Public: 00613994756701
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• 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): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 80