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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE¿ CARDIOTOMY / VENOUS RESERVOIR WITH CARMEDA OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS AFFINITY PIXIE¿ CARDIOTOMY / VENOUS RESERVOIR WITH CARMEDA OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number CBP241
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Blood Loss (2597)
Event Date 12/06/2018
Event Type  Injury  
Manufacturer Narrative
Inspection of the returned pixie reservoir indicated the pressure relief valve cap was still installed, potentially contributing to poor drainage/lines popping off. Additional visual inspection showed no outward signs of any damage including the vent port or any assembly errors. Investigation is ongoing. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use, the customer reported that when the patient went on bypass, the affinity pixie oxygenator/cvr drainage was very poor. One of the vent lines popped off the reservoir twice and caused blood loss. The volume of blood loss (ml) was not provided. The product was replaced. They came off bypass for about 3 minutes to change out reservoir. Cpr was needed at this time. The customer stated the only known patient impact was blood loss, patient status or other details were not provided. The replacement reservoir was used to complete the case.
 
Manufacturer Narrative
Investigation conclusion: complaint is not confirmed for the pixie oxygenator/cvr's poor drainage. Review of this unit's device history record found no abnormalities or ncmrs initiated during manufacturing that would cause or contribute to the reported event. The returned device pressure relief valve cap was still installed. The product ifu instructs the user to remove the obturator cap from the cvr positive/negative pressure relief valve and to ensure the cvr is vented to the atmosphere by removing the vent port cap during setup. Using the cvr without removing the obturator cap can contribute to poor drainage and vent lines popping off. Root cause is undetermined. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameAFFINITY PIXIE¿ CARDIOTOMY / VENOUS RESERVOIR WITH CARMEDA
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 Key8216338
MDR Text Key132038685
Report Number2184009-2019-00002
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberCBP241
Device Catalogue NumberCBP241
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2017
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: 01/04/2019 Patient Sequence Number: 1
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