BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 6151489 · Received December 7, 2016

    Report

    Report Number
    3003761017-2016-00383
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. REVIEW OF THE PATIENT FILE REVEALED NUMEROUS "EXTERNAL AIR CONNECTED" NOTIFICATIONS. THIS IS AN INDICATION THAT THE NECESSARY CONDITIONS REQUIRED FOR THE DRIVER TO OPERATE EXCLUSIVELY ON EXTERNAL AIR WERE NOT CONSISTENTLY MET, THEREBY CAUSING THE DRIVER TO DISABLE THE EXTERNAL AIR CONNECTED ICON AND ACTIVATE THE PRIMARY COMPRESSOR. THIS CONFIRMED THE CUSTOMER-REPORTED ISSUE. DURING INVESTIGATION TESTING, THE MANUAL PRESSURE REGULATOR WAS UNABLE TO MAINTAIN THE REQUIRED PRESSURE SET POINT VALUE AND WAS IDENTIFIED AS THE ROOT CAUSE OF THE CUSTOMER-REPORTED COMPRESSOR CYCLING WHILE THE DRIVER WAS CONNECTED TO WALL AIR. 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).

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE WALL AIR INDICATOR LIGHT DID NOT SHOW AS ON WHEN THE AIR HOSE WAS ENGAGED AND CONNECTED TO WALL AIR. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER COMPRESSOR CYCLED ON AND OFF WHILE THE DRIVER WAS CONNECTED TO WALL AIR. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO A BACKUP COMPANION 2 DRIVER WITH NO REPORTED ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE WALL AIR INDICATOR LIGHT DID NOT SHOW AS ON WHEN THE AIR HOSE WAS ENGAGED AND CONNECTED TO WALL AIR. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER COMPRESSOR CYCLED ON AND OFF WHILE THE DRIVER WAS CONNECTED TO WALL AIR. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO A BACKUP COMPANION 2 DRIVER WITH NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801613 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR