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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Device Problems Temperature Problem (3022); Noise, Audible (3273)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 11/09/2018
Event Type  malfunction  
Event Description
Pt is on centrally cannulated va ecmo via centrimag. Writer entered room because i heard a loud "whirring" noise; immediately realized it was the motor pump of the ecmo. This motor pump was also very hot to the touch. I alerted perfusion, cca, and my charge nurse. Perfusion came to the bedside, and we switched out the motor head. This is unsafe for the pt because he relies on ecmo and his blood pressure drops into the 30's during pump changes. Manufacturer response for "centramag" "echmo" device, (brand not provided) (per site reporter). The manufacturer is investigating what happened.
 
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Brand NameCENTRIMAG
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
6035 stoneridge dr
pleasanton CA 94588
MDR Report Key8178918
MDR Text Key130924514
Report Number8178918
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
Report Date 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/12/2018
Event Location Hospital
Date Report to Manufacturer12/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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