BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC CENTRIMAG VAD KIT, OUS

    MDR report key: 7145026 · Received December 22, 2017

    Report

    Report Number
    2916596-2017-03329
    Event Type
    Death
    Date Received
    December 22, 2017
    Date of Event
    December 6, 2017
    Report Date
    June 27, 2018
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    OJE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION- AGE OF DEVICE IS 32 DAYS. THE REPORT OF A WHITE OPAQUE DEPOSITION WITHIN THE VENOUS DRAINAGE CANNULA WAS CONFIRMED BASED ON SUBMITTED PHOTOGRAPHS. UPON EVALUATION OF THE RETURNED CANNULA, NO THROMBUS OR ANY OTHER DISPOSITION WERE OBSERVED WITHIN THE CANNULA. THEREFORE, SPECIFIC CHARACTERISTICS OF THE MATERIAL SUCH AS STRUCTURE AND TEXTURE COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE CANNULA WAS SUBSEQUENTLY FORWARDED TO THE MANUFACTURER, WHO PROVIDED THEIR EVALUATION OF THE RETURNED DEVICE. THE MANUFACTURER ISSUED A LETTER DATED 27MAR2018 SUMMARIZING THE INVESTIGATION PERFORMED ON THE CANNULA, THE EVALUATION OF THE CANNULA DID NOT REVEAL ANY DEVICE-RELATED ISSUES. THE LETTER FURTHER INDICATED THAT PER THEIR IFU, THEIR CANNULAE ARE ONLY INTENDED FOR CANNULA DRAINAGE FROM THE SUPERIOR AND INFERIOR VENA CAVA DURING EXTRACORPOREAL CIRCULATION FOR A DURATION OF LESS THAN 6 HOURS. HOWEVER, THE IFU INCLUDED IN THE CENTRIMAG VAD KIT, WHICH IS SPECIFIC TO THE DISPOSABLE CENTRIMAG BLOOD PUMP, HAS AN INDICATION FOR USE OF UP TO 30 DAYS. PER THE LETTER FROM THE MANUFACTURER CONCLUDED THE ROOT CAUSE FOR THE REPORTED EVENT WAS LIKELY DUE TO USE OF THE DEVICE OUTSIDE OF ITS INTENDED TIMEFRAME. ROOT CAUSE AND CORRECTIVE ACTION FOR THE LABELING ISSUE ARE BEING EVALUATED PER INTERNAL CAPA PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED AT CLINICA (B)(6). THE CENTRIMAG COMPONENTS WERE NOT RETURNED FOR EVALUATION. THE DRAINAGE CANNULA WAS FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). 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 PLACED ON EXTRACORPOREAL CIRCULATORY SUPPORT ON (B)(6) 2017. IT WAS REPORTED THAT THE VENOUS DRAINAGE CANNULA FROM ANOTHER MANUFACTURER HAD A CLOUDY WHITE COLOR, SUSPICIOUS OF A WHITE CLOT. THE PATIENT¿S LACTATE DEHYDROGENASE LEVEL INCREASED AND AN ECHOCARDIOGRAM SHOWED IMAGES COMPATIBLE WITH THROMBUS. PRIOR TO AND DURING THE SURGERY ON (B)(6) 2017 TO CHANGE THE CANNULA, THE PATIENT WAS DOING WELL. 24 HOURS POST-OPERATIVELY, THE PATIENT PRESENTED WITH MASSIVE BLEEDING. IT WAS ¿REVIEWED SURGICALLY¿ BUT THE BLEEDING COULD NOT BE CONTROLLED. REPORTEDLY, THE PATIENT EXPIRED DUE TO SURGICAL PROBLEMS AFTER CHANGING THE CANNULA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921293 THORATEC CENTRIMAG VAD KIT, OUS CENTRIMAG VAD KIT OJE THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| L| R