MAUDE Adverse Event Report: PERFUSION SYSTEMS CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number CB511

Device Problem Fluid Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the customer (not available for return to medtronic). If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use in an extra corporeal membrane oxygenation operation, the customer reported a leak at the interface between the fusion oxygenator and the custom pack tubing. The leak occurred 10 minutes following catheter connection. A 100ml blood loss was reported. A transfusion of one unit of red blood cells was given to the patient. The customer stated that the leak was the main reason for the transfusion. The device was replaced to complete the case. The patient status returned to normal following the transfusion. There was no adverse effect to the patient.

• Brand Name: CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9212705
• MDR Text Key: 195616618
• Report Number: 2184009-2019-00060
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K172626
• 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,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CB511
• Device Catalogue Number: CB511
• Device Lot Number: 216426918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/21/2019 Patient Sequence Number: 1