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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT I-CVR/HFO 541 OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS AFFINITY NT I-CVR/HFO 541 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 95214
Device Problems Fluid Leak (1250); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Patient Problem Low Oxygen Saturation (2477)
Event Date 11/28/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during heart surgery it was reported that the oxygenation capacity gradually decreased with use of an affinity nt oxygenator. The carbon dioxide removal capacity decreased and plasma leaked from the lower end of the oxygenator. The customer constantly increased the oxygen concentration and increased the air flow to compensate for gas exchange, and a blood transfusion was administered to compensate for blood oxygen and coagulation function. Patient outcome was described as alive, no injury.
 
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Brand NameAFFINITY NT I-CVR/HFO 541
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 Key9563832
MDR Text Key174178961
Report Number2184009-2020-00004
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K191029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/24/2020
Device Model Number95214
Device Catalogue Number95214
Device Lot Number13256543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/24/2018
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: 01/08/2020 Patient Sequence Number: 1
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