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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS MEDTRONIC AFFINITY FUSION OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS
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MEDTRONIC PERFUSION SYSTEMS MEDTRONIC AFFINITY FUSION OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Lot Number 226191593
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2024
Event Type  Injury  
Event Description
After initiating cardiopulmonary bypass, we could not reach full flow on cardiopulmonary bypass, the rpms were maxed out.Lines were checked for clamps and kinks.Albumin was in the prime.(b)(6) was called to the room to assist.Lines were checked again, we vented the oxygenator and went up and down on flow several times.Full flow could not be reached.After 10 minutes of being on pump, we tried to change the centrifugal pump head.We refilled the patient with blood and changed the pump head.This made a minimal improvement, but we could still not reach full flow.The decision was made to change the oxygenator.The oxygenator was swapped out with approximately 300ml of blood loss in the oxygenator.We deaired the lines and returned to bypass.We were able to reach full flow.The incident was reported to medtronic and they are evaluating the biohead and the oxygenator.
 
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Brand Name
MEDTRONIC AFFINITY FUSION OXYGENATOR
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC PERFUSION SYSTEMS
MDR Report Key19013814
MDR Text Key339123303
Report NumberMW5153436
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot Number226191593
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/29/2024
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other; Required Intervention;
Patient Age69 YR
Patient SexMale
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