BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 7052561 · Received November 22, 2017

    Report

    Report Number
    3003761017-2017-00233
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    November 11, 2017
    Report Date
    September 13, 2018
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SINGLE COMPRESSOR MALFUNCTION ALARM WAS CONFIRMED VIA A REVIEW OF THE PATIENT DATA FILE. THE SINGLE COMPRESSOR MALFUNCTION ALARM WAS FOUND TO HAVE OCCURRED WITHIN TWO MINUTES OF STARTUP. COMPARING THIS AGAINST THE PARAMETERS OBSERVED ONE MINUTE PRIOR TO THE ALARM SHOW THAT THE DRIVELINES WERE NOT CONNECTED TO A PATIENT OR MOCK TANK LOAD, WHICH CAN RESULT IN A SINGLE COMPRESSOR MALFUNCTION ALARM. THE CUSTOMER-REPORTED SYSTEM MALFUNCTION ALARMS WERE ALSO CONFIRMED BY REVIEW OF THE PATIENT DATA FILE AND ALARM HISTORY. THE TWO RESULTING FAULT CODES OBSERVED IN THE DRIVER WERE '3D' AND '35' FAULT CODES. THE FUNCTIONAL INSPECTION DETERMINED THE '3D' ALARM TO BE THE RESULT OF FAULTY SOLDER JOINTS ON THE LEFT AND RIGHT VACUUM CONNECTOR CONNECTIONS ON THE MAIN PCB (PRINTED CIRCUIT BOARD) ASSEMBLY (LACK OF SOLDER COVERAGE ON BOARD HEADERS J11 AND J19). WHILE THE ROOT CAUSE OF THE INSUFFICIENT SOLDER COVERAGE CANNOT BE DETERMINED, IT IS LIKELY THE RESULT OF A PRODUCTION DEFECT AT THE TIME THE HEADER WAS POPULATED TO THE PCB. THE FUNCTIONAL INSPECTION IDENTIFIED THAT A '35' FAULT CODE COULD BY TRIGGERED BY INCOMPLETE SETTING OF THE KEY SWITCH. MANIPULATION OF THE KEY SWITCHED PROVED THAT A SYSTEM MALFUNCTION ALARM CAN BE RECORDED IF THE KEY SWITCH IS IMPROPERLY OR INCOMPLETELY TURNED. THE ROOT CAUSE OF THIS CANNOT BE CONFIRMED, BUT IS LIKELY THE RESULT OF IMPROPER USE. THE KEY SHOULD NOT BE LEFT IN THE DRIVER DURING PATIENT SUPPORT. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE COMPANION 2 DRIVER EXHIBITED A SYSTEM MALFUNCTION ALARM, IT CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED A SYSTEM MALFUNCTION ALARM WHILE SUPPORTING A PATIENT. THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP COMPANION 2 DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834171 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR