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

Model Number CB511

Device Problem Air/Gas in Device (4062)

Patient Problem Cardiac Arrest (1762)

Event Date 03/08/2021

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported air bubbles in the custom pack's fusion oxygenator during ecmo. Use of the device was discontinued due to the patient's condition. The patient subsequently died. The reported device issue was thought by the customer to be associated with the patient's death. Additional information: the customer thought the yellow air bubbles were plasma serum, that event was recorded through the gas out at the period time 14hr, 30hr, 36hr respectively since the system was working. The recirculation port was used during priming/during the case. Large amounts of suction and venting were not used. There was no visible air in the system/tubing. A bubble detector was not used. The purge line was run open, attached to the port in the cardiotomy inlets.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11705734
• MDR Text Key: 246664944
• Report Number: 2184009-2021-00022
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K191029
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• 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: 219450648
• 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: 06/09/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 04/22/2021 Patient Sequence Number: 1