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U.S. Department of Health and Human Services

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

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PERFUSION SYSTEMS AFFINITY NT OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 95212
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluation summary: visual inspection shows a crack in the upper hex housing. Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes. During the pressure integrity testing there was a leak observed at the crack. Reason for return was confirmed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during the use of an affinity nt oxygenator, the customer observed a leak. The device was replaced to complete the procedure. There was no patient impact associated with this event. Medtronic received additional information that the amount of blood lost as a result of the leak was unknown. The patient did not require a transfusion because of the leak. Analysis of the returned device showed a crack in the upper hex housing of the device as the source of the reported leak.
 
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Brand NameAFFINITY NT 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key14286813
MDR Text Key290777676
Report Number2184009-2022-00096
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number95212
Device Catalogue Number95212
Device Lot Number13350063
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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