BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 7049631 · Received November 21, 2017

    Report

    Report Number
    3003761017-2017-00230
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    November 8, 2017
    Report Date
    November 8, 2017
    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 COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE CUSTOMER-REPORTED SYSTEM MALFUNCTION ALARM WAS VERIFIED THROUGH A PATIENT FILE REVIEW AND COINCIDED WITH A LOSS OF VACUUM PERFORMANCE AND WAS REPRODUCED DURING INVESTIGATION TESTING. THE ROOT CAUSE WAS DETERMINED TO BE A LOSS OF THE RIGHT VACUUM CAUSED BY A DAMAGED SOLDER JOINT AT J19 ON THE MAIN BOARD PRINTED CIRCUIT ASSEMBLY. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Description of Event or Problem · 0

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT WHEN CHANGING THE RIGHT VACUUM, 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.

    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).

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT WHEN CHANGING THE RIGHT VACUUM, 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
    829038 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR