BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC CENTRIMAG MOTOR

    MDR report key: 3839437 · Received May 15, 2014

    Report

    Report Number
    2916596-2014-00792
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 2, 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 MOTOR WAS RETURNED TO THE MFR FOR EVALUATION 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 THE PERFUSIONIST HEARD AN ALARM ON THE CONSOLE AND AS HE APPROACHED THE PT HE REALIZED IT WAS THE LOW FLOW ALARM. THIS ALARM HAD BEEN ACTIVATED PREVIOUSLY A FEW TIMES WHILE THE PT WAS ON SUPPORT; HOWEVER, THIS TIME THE FLOW HAD GONE TO ZERO. THE PERFUSIONIST REPORTED THAT THE RPM WAS AT 4000 AND THE PT'S PRESSURE HAD DROPPED. HE FELT THE MOTOR AND COULD FEEL VIBRATIONS THEREFORE, HE SWITCHED TO A BACKUP FLOW PROBE AND THE ALARM WAS NOT CLEARED. THE HOSPITAL TEAM STARTED CHECK COMPRESSIONS AND THE PERFUSIONIST CLAMPED THE ARTERIAL LINE AND SWITCHED TO THE BACKUP CONSOLE. HE INCREASED THE RPM TO 4000 AGAIN AND A FLOW OF AROUND 4.2 L WAS IMMEDIATELY GENERATED. THE FLOW TO THE PT HAD BEEN INTERRUPTED FOR APPROXIMATELY 5 MINUTES. APPROXIMATELY 5 DAYS LATER, THE PT EXPIRED AND THE CAUSE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289632 THORATEC CENTRIMAG MOTOR KFM: CENTRIMAG MOTOR KFM THORATEC SWITZERLAND GMBH. 201-10002 L00044

    Patients

    Seq Age Sex Outcome Treatment
    1 Death