BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 12555605 · Received September 30, 2021

    Report

    Report Number
    3003761017-2021-00193
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 20, 2021
    Report Date
    March 3, 2022
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER-REPORTED ISSUE WAS CONFIRMED BY PATIENT FILE REVIEW. THE ROOT CAUSE OF THE FAULT ALARM WAS DETERMINED TO BE THE DRIVER STARTING UP WITHOUT A LOAD. SINCE THE COMPANION 2 DRIVER'S DRIVELINES ARE NOT CONNECTED TO A PATIENT AT DRIVER START UP, THERE IS NO LOAD ON THE SYSTEM. THIS CAN CAUSE ADDITIONAL STRESS ON THE COMPRESSOR OCCASIONALLY CAUSING A SINGLE COMPRESSOR MALFUNCTION ALARM. THE ALARM IS RECORDED IMMEDIATELY; HOWEVER, IT DOES NOT APPEAR ON THE COMPANION 2 DRIVER DISPLAY OR ANNUNCIATE UNTIL THE GUI SOFTWARE HAS COMPLETED ITS FULL BOOT-UP WHICH TAKES APPROXIMATELY TWO MINUTES. INVESTIGATION TESTING DETERMINED THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. SYNCARDIA HAS A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO ADDRESS THIS ISSUE. (SECTION H6 CODES - 3189, 4755, 213, 67). DURING INCOMING TESTING, THE DRIVER FAILED MULTIPLE STEPS BECAUSE THE EMERGENCY BATTERY WAS UNABLE TO POWER THE DRIVER AND THE DRIVER DISPLAYED A PERSISTENT EMERGENCY BATTERY ERROR ALARM. THE EMERGENCY BATTERY WAS EVALUATED AND FOUND TO HAVE AN UNRECOVERABLE PERMANENT FAULT CODE. (SECTION H6 CODES 3010, 420, 3227, 4307). THESE ISSUES WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS INVESTIGATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED A SINGLE COMPRESSOR MALFUNCTION ALARM DURING START UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456108 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown