BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG MOTOR

    MDR report key: 3763362 · Received April 16, 2014

    Report

    Report Number
    2916596-2014-00596
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 19, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED WITH AN ACUTE BLOOD PUMP SYSTEM. IT WAS REPORTED THAT THE MOTOR BECAME HOT AND STOPPED. CPR WAS INITIATED ON THE PATIENT AND A REPLACEMENT MOTOR WAS CONNECTED. THE PATIENT REMAINS ONGOING AND NO FURTHER EVENTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232074 THORATEC CENTRIMAG MOTOR KFM: CENTRIMAG MOTOR KFM THORATEC SWITZERLAND GMBH 201-10002 L02209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention