BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC CENTRIMAG

    MDR report key: 5680881 · Received May 25, 2016

    Report

    Report Number
    2916596-2016-00980
    Event Type
    Death
    Date Received
    May 25, 2016
    Date of Event
    June 1, 2015
    Report Date
    April 28, 2016
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT AND THE DATE OF DEATH ARE ESTIMATED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED, THEREFORE, THE EXPIRATION DATE, MANUFACTURE DATE AND DEVICE UNIQUE IDENTIFIER (UDI) ARE UNKNOWN. APPROXIMATE AGE OF DEVICE ¿ 10 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED. THROMBOEMBOLIC PHENOMENA IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE CENTRIMAG BLOOD PUMP. THE INSTRUCTIONS FOR USE WARNS TO ALWAYS HAVE A SPARE CENTRIMAG BLOOD PUMP, BACK-UP CONSOLE, AND EQUIPMENT AVAILABLE FOR CHANGEOUT. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO DEVICE PLACEMENT, THE PATIENT HAD BEEN IN THE INTENSIVE CARE UNIT FOR APPROXIMATELY 6 MONTHS DUE TO DILATED CARDIOMYOPATHY. THE PATIENT'S BLOOD PRESSURE WAS UNABLE TO BE MAINTAINED AND ON AN UNSPECIFIED DATE THE PATIENT WAS EMERGENTLY PLACED ON BIVENTRICULAR EXTRACORPOREAL CIRCULATORY LIFE SUPPORT (ECLS) WITH EXTRACORPOREAL MEMBRANOUS OXYGENATION (ECMO). ON DAY 4 OF SUPPORT, A LARGE CLOT WAS OBSERVED WITHIN THE BLADES OF THE LEFT VENTRICLE PUMP THAT REPORTEDLY CAUSED THE UNIT TO VIBRATE. THE PUMP WAS EXCHANGED. ON DAY 9 OF SUPPORT A FLOATING THROMBUS WAS OBSERVED WITHIN THE WIRE OUTLET CONNECTOR AT THE DISTAL END OF THE LEFT VENTRICLE CANNULA/CIRCUIT. THE PATIENT'S SURGEON DETERMINED THAT THE LEFT VENTRICLE CANNULA WOULD NOT BE EXCHANGED AS AN URGENT TRANSPLANT WAS SCHEDULED FOR 5 AM THE FOLLOWING MORNING. THE PATIENT REPORTEDLY EXPERIENCED UNSPECIFIED NEUROLOGICAL DEFICITS AFTER THE CLOT WAS NOTED AND THE PATIENT EXPIRED ONE DAY POST-TRANSPLANT DUE TO THEIR NEUROLOGICAL CONDITION. THE PERFUSIONIST REPORTEDLY FELT THAT THE CLOTTING ISSUE WAS UNRELATED TO THE ECLS DEVICE, BUT WAS RATHER DUE TO THE ANTICOAGULATION MANAGEMENT PROTOCOL IN A PATIENT WHO WAS HYPERCOAGULABLE. A THROMBOELASTOGRAPH (TEG) HAD BEEN PERFORMED WHEN THE PATIENT WAS FIRST PLACED ON BIVENTRICULAR ECLS AND ECMO SUPPORT AND THE RESULTS HAD INDICATED THAT THE PATIENT WAS HYPERCOAGULABLE. SUBSEQUENT TO THE INITIAL TEG EVALUATION, THE PATIENT'S ANTICOAGULATION STATUS WAS MONITORED USING HIGH RANGE ACTIVATED CLOTTING TIME (ACT) VALUES. THE SPECIFIC RESULTS, AND THE ANTICOAGULATION MEDICATIONS BEING ADMINISTERED WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333563 THORATEC CENTRIMAG CENTRIMAG BLOOD PUMP KFM THORATEC SWITZERLAND GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Death