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U.S. Department of Health and Human Services

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

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PERFUSION SYSTEMS CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameCARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR
Type of DeviceOXYGENATOR, 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 Key11705734
MDR Text Key246664944
Report Number2184009-2021-00022
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K191029
Number of Events Reported1
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 Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCB511
Device Catalogue NumberCB511
Device Lot Number219450648
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 Received06/09/2021
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
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