BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC CENTRIMAG

    MDR report key: 7061593 · Received November 27, 2017

    Report

    Report Number
    2916596-2017-02929
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 6, 2017
    Report Date
    June 7, 2018
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF A CLOT IN THE BLOOD PUMP WAS CONFIRMED THROUGH A SUBMITTED PHOTOGRAPH. REVIEW OF THE SUBMITTED PHOTO REVEALED A THROMBUS FORMATION WITHIN THE BLOOD PUMP. THE THROMBUS WAS RED IN COLOR AND WAS SITUATED AROUND THE PUMP ROTOR. BASED ON THE PHOTO, THE THROMBUS APPEARED TO HAVE A STRINGY STRUCTURE AND DID NOT APPEAR TO HAVE FORMED IN LAMINATED LAYERS. THE ORIGIN AND A DURATION OF TIME FOR WHICH THE THROMBUS WAS PRESENT IN THE BLOOD PUMP COULD NOT BE DETERMINED. A SPECIFIC CAUSE FOR THE DEVELOPMENT OF THE THROMBUS FORMATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION; HOWEVER, THE ACCOUNT NOTED THAT THE PATIENT WAS NOT ON ANTICOAGULATION THERAPY AT THE TIME OF THE EVENT. THE THROMBUS FORMATION WAS VERY LARGE AND ALMOST COMPLETELY COVERED THE PUMP ROTOR. ALTHOUGH A ROOT CAUSE FOR THE REPORTED OVERHEATING OF THE MOTOR COULD NOT BE CONCLUSIVELY CONFIRMED WITHOUT A FULL EVALUATION OF THE MOTOR AND BLOOD PUMP, BASED ON PREVIOUS COMPLAINT EXPERIENCE, THE THROMBUS WITHIN THE BLOOD PUMP COULD HAVE POTENTIALLY CAUSED AN INCREASE IN DRAG ON THE SPINNING ROTOR AND AN INCREASE IN POWER REQUIREMENT TO RESULT IN THE GENERATION OF EXCESSIVE MOTOR HEAT. THIS IS CONSISTENT WITH THE ACCOUNT''S REPORT THAT THE MOTOR WAS NOT THE SOURCE OF THE PROBLEM AS A BACKUP MOTOR OVERHEATED AS WELL AND THE ISSUE RESOLVED AFTER CHANGING OUT THE BLOOD PUMP. THE BLOOD PUMP WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S AGE, WEIGHT AND DATE OF BIRTH WERE NOT PROVIDED. (B)(4). THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED, THEREFORE THE MANUFACTURE DATE, EXPIRATION DATE, AND THE AGE OF THE DEVICE ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER''S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING SUPPORTED BY AN EXTRACORPOREAL CIRCULATORY SUPPORT PUMP. IT WAS REPORTED THAT THE MOTOR OVERHEATED DUE TO A CLOT IN THE BLOOD PUMP WHICH LED TO A PUMP EXCHANGE. THE PATIENT WAS NOT ON ANY ANTICOAGULATION THERAPY AND WAS ALSO IMPLANTED WITH ANOTHER COMPANY¿S LVAD AT THE TIME OF THE EVENT. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837937 THORATEC CENTRIMAG CENTRIMAG BLOOD PUMP KFM THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1