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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH/ ABBOTT LABORATORIES CENTRIMAG PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH/ ABBOTT LABORATORIES CENTRIMAG PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Lot Number L01954-0009
Device Problem No Flow (2991)
Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Event Date 03/10/2021
Event Type  malfunction  
Event Description
While moving centrimag motor/console from ecmo cart to patient stretcher to transport an ecmo patient to ct scan, the flow and rpms went to zero. The perfusionist doing the transport immediately attempted to go up/down on rpm's with no change occurring. She then clamped the circuit and switched the head over to the backup, restoring ecmo flows. During this brief period the patient desaturated and became hypotensive, epi was pushed and respiratory was actively ventilating. No chest compressions were done, patient did not go asystole. Fda safety report id # (b)(4).
 
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Brand NameCENTRIMAG PRIMARY CONSOLE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH/ ABBOTT LABORATORIES
MDR Report Key11541460
MDR Text Key241815222
Report NumberMW5100150
Device Sequence Number1
Product Code DWA
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberL01954-0009
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/19/2021 Patient Sequence Number: 1
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