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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC AFFINITY; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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MEDTRONIC, INC AFFINITY; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Lot Number 221503567
Device Problems Decoupling (1145); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 03/26/2021
Event Type  malfunction  
Event Description
Extracorporeal membrane oxygenation (ecmo) started alarming.Ecmo cone exchanged due to decoupling.At approximately 0415, a motor-sounding noise was noted coming from patient's room by myself.Primary rn in alcove notified of sound.Perfusionist immediately called to bedside.Cone changed between 0417-0417.
 
Event Description
Extracorporeal membrane oxygenation (ecmo) started alarming.Ecmo cone exchanged due to decoupling.At approximately 0415, a motor-sounding noise was noted coming from patient's room by myself.Primary rn in alcove notified of sound.Perfusionist immediately called to bedside.Cone changed between 0417-0417.
 
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Brand Name
AFFINITY
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC, INC
8200 coral sea st ne # mvs74
moundsview MN 55112
MDR Report Key11684913
MDR Text Key245997449
Report Number11684913
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number221503567
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2021
Event Location Hospital
Date Report to Manufacturer04/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18250 DA
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