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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
Model Number 6596259
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Vibration (1674); Noise, Audible (3273)
Patient Problem No Information (3190)
Event Date 03/20/2019
Event Type  malfunction  
Event Description
Bedside rn called mcs rn into patient room with centrimag alarming. Bedside rn stating that pump head made high pitched whirling noise about 30 seconds before machine started alarming. Mcs rn noted both console's to be off while display monitor showing speed to be 3800 while flow was dashed out. Pump head making high pitched noise and increased vibration felt. After turning on the back up console, it was noted that the original console now back on and showing what the display is showing. Able to turn speed down and clamp in order to switch to the new pump/console.
 
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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 Key8543723
MDR Text Key142883472
Report Number8543723
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 03/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6596259
Device Catalogue Number201-30300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2019
Event Location Hospital
Date Report to Manufacturer04/24/2019
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? No
Type of Device Usage

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