BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC CENTRIMAG

    MDR report key: 4163493 · Received July 17, 2014

    Report

    Report Number
    2916596-2014-01203
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED FOR EVALUATION; THEREFORE A SPECIFIC CAUSE FOR THE FLOW ISSUE COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE REPLACEMENT PUMP WAS NOT RETURNED, BUT WAS REPORTED TO FUNCTION AS INTENDED AND THE PATIENT¿S OUTCOME WAS NOT BELIEVED TO BE DEVICE OR THERAPY RELATED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE VAD COORDINATOR REPORTED THAT, DURING THE PREPPING THE IMPLANTATION AN ACUTE BLOOD PUMP SYSTEM FOR VENTRICULAR SUPPORT, THEY COULD NOT GET ANY FLOW WITH CURRENT PUMP PRIOR TO CONNECTING TO THE PT. DESPITE INCREASING RPM TO OVER 4000, THEY COULD NOT GET TO 1 LITER. THE FLOW PROBE WAS CHANGED, OXYGENATOR WAS CHANGED TWICE WITH TWO DIFFERENT BRANDS, CHANGED CONSOLES, SWITCHED TO A DIFFERENT MOTOR, AND STILL COULD NOT GET FLOW. A NEW PUMP WAS STARTED AND REPRIMED WITH NO ISSUES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE FIRST PUMP WAS NEVER IMPLANTED ON THE PATIENT BECAUSE THEY COULD NOT GET ANY FLOW WHEN THEY PRIMED THE PUMP. THE SPEED WAS TURNED UP VERY HIGH AND STILL THE PUMP WAS GETTING LESS THAN A LITER OF FLOW. THERE WAS QUESTION WHETHER THE PUMP WAS WORKING PROPERLY. SO THEY STARTED OVER WITH NEW EVERYTHING AND THE REPLACEMENT PUMP WORKED FINE. THE PATIENT WAS ONLY SUPPORTED BY THE REPLACEMENT PUMP FOR LESS THAN 24 HOURS. THE REPLACEMENT PUMP WORKED AS EXPECTED. THE HOSPITAL STAFF DO NOT BELIEVE THE PATIENT'' DEATH WAS DEVICE OR THERAPY RELATED. THE PATIENT CODED TWICE BEFORE SECOND PUMP WAS EVEN PLACED. THE PATIENT'S EEG SHOWED NO ACTIVITY THE NEXT MORNING. THE PUMP WAS USED FOR ECMO JUST TO SEE IF IT WOULD GIVE HIM A CHANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419012 THORATEC CENTRIMAG KFR: CENTRIMAG BLOOD PUMP KFM THORATEC SWITZERLAND GMBH 102953 L03133-LA07

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other