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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE HFO AND PIXIE CVR OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS AFFINITY PIXIE HFO AND PIXIE CVR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BBP241
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Sepsis (2067)
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that post use of a pixie oxygenator, the customer reported the patient had an infection and subsequently died from sirs and septic shock.
 
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Brand NameAFFINITY PIXIE HFO AND PIXIE CVR
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 Key11775814
MDR Text Key248991914
Report Number2184009-2021-00030
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeAF
PMA/PMN Number
K183511
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
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Model NumberBBP241
Device Catalogue NumberBBP241
Device Lot Number13339133
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 Received06/24/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/31/2020
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: 05/05/2021 Patient Sequence Number: 1
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