BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC CENTRIMAG MOTOR

    MDR report key: 3924985 · Received June 18, 2014

    Report

    Report Number
    2916596-2014-01017
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 21, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS SUPPORTED WITH AN ACUTE BLOOD PUMP SYSTEM. IT WAS REPORTED THAT DURING PT TRANSPORT AND WHILE THE PT WAS ON ECMO, THE PRIMARY CONSOLE HAD A M4 MOTOR ALARM. IT WAS ALSO REPORTED THAT THE MOTOR DID NOT STOP AND CONTINUED TO SUPPORT THE PT; HOWEVER, THE MOTOR GOT HOT, THE ALARM SOUNDED AND THE PRIMARY CONSOLE REGISTERED A MESSAGE. "MOTOR OVER HEATED". THE PT WAS SWITCHED TO A BACKUP SYSTEM. THE HOSPITAL REPORTED THAT IT TOOK 30 SECONDS TO CHANGE TO THE BACKUP SYSTEM, THEREFORE, THE PT WAS HEMODYNAMIC COMPROMISED FOR 30 SECONDS. IT WAS REPORTED THAT THE EVENT DID NOT LEAD TO ANY INJURY TO THE PT AND DID NOT COMPROMISE THE PT'S OUTCOME. THE PT EXPIRED ON (B)(6), 2014 AND THE REPORTED CAUSE OF DEATH WAS MULTI-ORGAN SYSTEM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358479 THORATEC CENTRIMAG MOTOR KFM: CENTRIMAG MOTOR KFM THORATEC SWITZERLAND GMBH 201-10002 500454

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death