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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC AFFINITY FUSION OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS
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MEDTRONIC AFFINITY FUSION OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BB811
Device Problem Mechanical Problem (1384)
Patient Problem Abnormal Blood Gases (1034)
Event Date 05/02/2017
Event Type  Injury  
Event Description
Issue: the patient was placed on cardiopulmonary bypass without event; however, after the first blood gas, patient was retaining co2.I was able to oxygenate the patient but unable to adequately remove co2.The o2/room air, vaporizer, blender (electronic and manual) were ruled out for complications.Determined to be the oxygenator unit.Patient was weaned from cardiopulmonary bypass without incident.Following up with (b)(4), fda report, report to manufacturer, and securing backup disposables from (b)(4), a separate third party cardiopulmonary bypass disposable provider.
 
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Brand Name
AFFINITY FUSION OXYGENATOR
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC
minneapolis MN 55432
MDR Report Key6543756
MDR Text Key74543038
Report NumberMW5069563
Device Sequence Number1
Product Code DTZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Model NumberBB811
Device Lot Number8110507783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2017
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
COUPLE OF YEARS. ; INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE; IS A PART OF. THIS IS A CUSTOM PACK THAT HAS BEEN ; MEDTRONIC AFFINITY FUSION OXYGENATOR WITH; MEDTRONIC CUSTOMER TUBING PACK, WHICH THE ; USED AT OUR FACILITIES FOR AT LEAST THE LAST
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight76
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