BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC CENTRIMAG MOTOR

    MDR report key: 3880417 · Received April 8, 2014

    Report

    Report Number
    2916596-2014-00530
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 10, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USAGE OF THE DEVICE: THE MOTOR IS NOT LABELED FOR SINGLE USE. THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR EVALUATION. 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 IN THE CARDIAC CATH LAB FOR ARRHYTHMIA ABLATION AND WAS BEING PREPPED FOR SUPPORT BY AN ACUTE BLOOD PUMP SYSTEM. IT WAS REPORTED THAT DURING THE INITIATION OF ECMO SUPPORT AND PRIOR TO CONNECTION TO THE PT, THE PRIMARY CONSOLE DID NOT DETECT THE MOTOR THAT WAS CONNECTED. IT IS UNK IF THE CONSOLE HAD ALARMED AND THE OPTION TO SET THE RPM WAS NOT DISPLAYED. AFTER MANIPULATING THE CABLES AND REINSERTING THE BLOOD PUMP THE SITUATION WAS RESOLVED. DURING PT SUPPORT IT WAS REPORTED THAT THERE WAS A SHORTAGE IN THE BATTERY CAPACITY. THE PRIMARY CONSOLE WAS DISCONNECTED FROM THE AC POWER SUPPLY AND THE PUMP STOPPED SHORTLY AFTER. THE PUMP FLOW WAS AT ZERO AND A "MOTOR" DISCONNECTED" ALARM WAS ACTIVE. THE PRIMARY CONSOLE, MOTOR AND FLOW PROBE WERE THEN EXCHANGED AND NO EFFECTS TO THE PT WERE REPORTED AT THE TIME OF THE EVENT. IT WAS ALSO REPORTED THAT THE PT'S CONDITION HAD IMPROVED. THE PT WAS STABILIZED, NEUROLOGICAL STATUS WAS OKAY, WAS NOT ON INOTROPES AND HOMODYNAMIC SUPPORT WAS DISCONTINUED. AN UNK TIME LATER THE PT HAD EXPIRED AND THE REPORTED CAUSE OF DEATH WAS "ORIGINAL DISEASES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210899 THORATEC CENTRIMAG MOTOR CENTRIMAG MOTOR KFM THORATEC SWITZERLAND GMBH 201-10002 L00238

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other