BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 5250420 · Received November 25, 2015

    Report

    Report Number
    3003761017-2015-00382
    Event Type
    Death
    Date Received
    November 25, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: COMPANION 2 DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2015-00291) AND COMPANION 2 DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2015-00382). THE CUSTOMER REPORTED THAT ON (B)(6) 2015, THE PATIENT WAS FOUND DECEASED IN HIS ASSISTED-LIVING FACILITY APARTMENT WITH THE COMPANION DRIVELINES DISCONNECTED FROM THE COMPANION 2 DRIVER IN HIS HAND. THE CUSTOMER REPORTED THAT TWO COMPANION 2 DRIVERS, S/N (B)(4), AND S/N (B)(4), WERE ASSIGNED TO THE PATIENT AT THE TIME OF THE CUSTOMER REPORTED EVENT. THE CUSTOMER REPORTED THAT COMPANION 2 DRIVER S/N (B)(4) WAS IN USE AT THE TIME OF THE REPORTED EVENT. THE PATIENT FILE WAS COPIED AND REVIEWED. ANALYSIS OF THE DATA DETERMINED THAT DRIVER S/N (B)(4) WAS NOT SUPPORTING THE PATIENT, DRIVER S/N (B)(4) WAS THE BACKUP DRIVER AND NOT THE PRIMARY DRIVER AS REPORTED BY THE CUSTOMER. DRIVER S/N (B)(4) WAS THE PRIMARY DRIVER AT THE TIME OF THE CUSTOMER REPORTED EVENT. THIS WAS DETERMINED BY COMPARING THE CARDIAC DATA / ALARM HISTORY FROM THE DRIVERS, S/N (B)(4) AND S/N (B)(4), THAT WERE ASSIGNED TO THE PATIENT AT THE TIME OF THE CUSTOMER REPORTED EVENT. DUE TO THE INVESTIGATION FINDINGS THAT DRIVER S/N (B)(4) WAS THE PRIMARY DRIVER, THIS CUSTOMER EXPERIENCE WAS REEVALUATED AND IT WAS DETERMINED TO BE A REPORTABLE EVENT TO FDA. VISUAL INSPECTION OF THE DRIVER'S "AS RECEIVED" CONDITION REVEALED NO ANOMALIES. THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL REQUIRED FUNCTIONAL AND PERFORMANCE TESTING AND FUNCTIONED AS INTENDED INCLUDING THE PROPER ANNUNCIATION OF AUDIBLE ALARMS AND PRESENTATION OF VISUAL INDICATORS. BASED ON THE INVESTIGATION RESULTS AND REVIEW OF THE ELECTRONIC PATIENT FILE AT THE TIME OF THE CUSTOMER REPORTED ISSUE, THE DRIVER FUNCTIONED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE COMPANION 2 DRIVER S/N (B)(4) WAS SERVICED AND MET ALL PERFORMANCE TEST ACCEPTABLE CRITERIA BEFORE BEING RELEASED TO FINISHED GOODS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779668 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death