BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG PRIMARY CONSOLE

    MDR report key: 6092764 · Received November 10, 2016

    Report

    Report Number
    2916596-2016-02194
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 14, 2016
    Report Date
    May 4, 2017
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION - MULTIPLE REQUESTS WERE MADE; HOWEVER, THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE EVENT COULD NOT BE CORRELATED TO A DEVICE RELATED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S AGE AND WEIGHT WERE NOT PROVIDED. THE REFERENCED 1ST PRIMARY CONSOLE THAT FAILED WAS REPORTED UNDER MEDWATCH MFR REPORT #2916596-2016-02193. THE PRIMARY CONSOLE IS NOT A SINGLE USE DEVICE. THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED, THEREFORE THE APPROXIMATE AGE OF THE DEVICE, MANUFACTURE DATE AND DEVICE UNIQUE IDENTIFIER (UDI) ARE UNKNOWN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT HAS NOT YET BEEN RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED ON LEFT VENTRICULAR EXTRACORPOREAL CIRCULATORY SUPPORT ON (B)(6) 2016. IT WAS REPORTED THAT ON (B)(6) 2016, THE PRIMARY CONSOLE "FAILED". THE PUMP SPEED AND PUMP FLOW REMAINED AT 0 RPM AND 0 LPM RESPECTIVELY. THE PATIENT WAS SWITCHED TO THE BACK-UP PRIMARY CONSOLE WHICH ALSO FAILED. THERAPY WAS RESTORED WHEN THE PATIENT WAS SWITCHED TO A THIRD PRIMARY CONSOLE. IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC; HOWEVER, THE SPECIFIC SYMPTOMS WERE NOT PROVIDED. IT WAS REPORTED THAT THE USER FACILITY BELIEVED THAT THE ISSUE MAY BE DUE TO BATTERY MAINTENANCE, WHICH IS BEING ADDRESSED BY ENSURING THAT BATTERY MAINTENANCE IS BEING DONE ROUTINELY AND PROPERLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745256 THORATEC CENTRIMAG PRIMARY CONSOLE CENTRIMAG PRIMARY CONSOLE DWA THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R