BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3876260 · Received June 4, 2014

    Report

    Report Number
    3003761017-2014-00079
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALSO REPORTED THAT THE NURSE IMMEDIATELY RECONNECTED THE COMPANION 2 DRIVER TO EXTERNAL WALL POWER AT THE WALL OUTLET AND RECONNECTED THE COMPRESSED AIR LINE TO THE WALL COMPRESSED AIR OUTLET, AND THE COMPANION 2 DRIVER STARTED PUMPING AND THE PATIENT REGAINED CONSCIOUSNESS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT APPEARED TO HAVE SUFFERED NO RESIDUAL ADVERSE EFFECTS FROM THE DISCONNECTION OF THE COMPANION 2 DRIVER FROM THE EXTERNAL POWER OUTLET AND COMPRESSED AIR OUTLET, WHICH RESULTED IN BATTERY DEPLETION AND EVENTUAL LOSS OF POWER. SYNCARDIA HAS NO DOCUMENTATION AS TO HOW THE COMPANION 2 DRIVER BECAME UNPLUGGED FORM THE EXTERNAL WALL OUTLET AND THE EXTERNAL COMPRESSED AIR OUTLET. AT THIS TIME, THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE PATIENT WAS SWITCHED TO A BACKUP COMPANION 2 DRIVER, AND THE COMPANION 2 DRIVER THAT IS THE SUBJECT OF THE REPORTED ISSUE WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS FO THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6) 2013. AT THE TIME OF THE REPORTED ISSUE, HE WAS SUPPORTED BY A SYNCARDIA COMPANION 2 DRIVER. THE CUSTOMER REPORTED THAT THE NURSING STAFF WAS ALERTED TO THE PATIENT'S ROOM BY A "LOSS OF POWER" AUDIBLE ALARM FROM THE COMPANION 2 DRIVER. THE CUSTOMER ALSO REPORTED THAT WHEN THE NURSE ENTERED THE ROOM, SHE OBSERVED THAT THE PATIENT WAS UNCONSCIOUS, THE COMPANION 2 DRIVER WAS DISCONNECTED FORM EXTERNAL WALL POWER AT THE WALL OUTLET, AND THE COMPRESSED AIR LINE WAS DISCONNECTED FORM THE WALL COMPRESSED AIR OUTLET. THE CUSTOMER ALSO REPORTED THAT BOTH THE COMPANION 2 DRIVER'S EXTERNAL BATTERIES AND THE INTERNAL, EMERGENCY BATTERY WERE DEPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326990 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR