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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 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.
 
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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
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key9212705
MDR Text Key195616618
Report Number2184009-2019-00060
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K172626
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 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCB511
Device Catalogue NumberCB511
Device Lot Number216426918
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 Received01/22/2020
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
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