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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BB811
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
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Brand NameFUSION 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key15050119
Report Number2184009-2022-00172
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00643169178168
UDI-Public00643169178168
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K183490
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberBB811
Device Catalogue NumberBB811
Device Lot Number13374686
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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