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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS AFFINITY PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BBP211
Device Problem Fluid/Blood Leak (1250)
Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2021
Event Type  Injury  
Manufacturer Narrative
Visual inspection shows evidence of a fiber leak with blood staining on the top and bottom of the fiber bundle. Performance analysis: pressure integrity testing was performed at 1 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes. During the pressure integrity testing there were no leaks observed from the device. Conclusion: reason for return was visually confirmed; however, it was not replicated during pressure testing. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of this oxygenator after 35 minutes of bypass there was a plasma-leakage from the lower level of the oxygenator. The oxygenator started to make foam in the section above the lower connection and heat exchanger. There was no leak noted during preparation and de-airing pre ecc.  the or teams set up increased surveillance of the leak, and the intervention continued to its end with a significant risk if the situation had deteriorated. Less than 50 ml of blood was lost due to the leak, and a transfusion was required. There is no adverse patient effects associated with this event. Additional information: the patient was kept at a low temperature to allow for a possible change of oxygenator. The team prepared a spare oxygenator to prevent a possible replacement if the problem worsened during the rest of the procedure. There were no hemodynamic consequences for the patient during the procedure and post-operative; however there was a significant risk to the patient if the oxygenator had to be changed. There was no damage to the device, the packaging or other contents within the package. Arterial and venous flow rates and pressures ranged from 1. 37 l/min to 1. 920 l/min depending on the patient temperature. Pressure from 88 mmhg to 200 mmhg. There was no air in the system/tubing.
 
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Brand NameAFFINITY PIXIE PEDIATRIC 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 Key12525938
MDR Text Key273198598
Report Number2184009-2021-00084
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K183511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2022
Device Model NumberBBP211
Device Catalogue NumberBBP211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2020
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: 09/24/2021 Patient Sequence Number: 1
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