BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 4922561 · Received July 13, 2015

    Report

    Report Number
    3003761017-2015-00220
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER WAS FUNCTIONING WHEN TURNED ON. HOWEVER, WHEN THE COMPANION 2 DRIVER WAS CONNECTED TO THE PATIENT, IT EXHIBITED A "SINGLE COMPRESSOR MALFUNCTION ALARM." THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO THE BACKUP COMPANION 2 DRIVER WITHOUT ANY REPORTED ADVERSE PATIENT IMPACT. THE CUSTOMER ALSO REPORTED THE CLINIC STAFF TURNED THE COMPANION 2 DRIVER ON AGAIN. THE DRIVER DID NOT EXHIBIT THE SINGLE COMPRESSOR MALFUNCTION ALARM. THE CLINIC STAFF PUT THE COMPANION 2 DRIVER BACK ON THE PATIENT WHEN THE DRIVER EXHIBITED THE SINGLE COMPRESSOR MALFUNCTION ALARM AGAIN. THE PATIENT WAS SWITCHED TO THE BACKUP COMPANION 2 DRIVER AGAIN. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. REVIEW OF THE ELECTRONIC PATIENT FILE REVEALED FOUR RECORDED SINGLE COMPRESSOR MALFUNCTION ALARMS. THIS CONFIRMED THE CUSTOMER-REPORTED ISSUE. EFFORTS TO REPRODUCE THE "SINGLE COMPRESSOR MALFUNCTION" ALARM WHILE OPERATING THE DRIVER UNDER THE SAME CONDITIONS AS THE CUSTOMER WERE SUCCESSFUL. THE ROOT CAUSE OF THE REPORTED ALARM WAS A MALFUNCTION OF THE LEFT COMPRESSOR. THE LEFT COMPRESSOR WAS REPLACED, AND THE COMPANION 2 DRIVER PASSED ALL FINAL PERFORMANCE TESTING. THIS FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE DRIVER WAS NOT SUPPORTING A PATIENT. IN ADDITION, IT WOULD NOT PREVENT THE DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER WAS FUNCTIONING WHEN TURNED ON. HOWEVER, WHEN THE COMPANION 2 DRIVER WAS CONNECTED TO THE PATIENT, IT EXHIBITED A "SINGLE COMPRESSOR MALFUNCTION ALARM". THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO THE BACKUP COMPANION 2 DRIVER W/OUT ANY REPORTED ADVERSE PATIENT IMPACT. THE CUSTOMER ALSO REPORTED THE CLINIC STAFF TURNED THE COMPANION 2 DRIVER ON AGAIN. THE DRIVER DID NOT EXHIBIT THE SINGLE COMPRESSOR MALFUNCTION ALARM. THE CLINIC STAFF PUT THE COMPANION 2 DRIVER BACK ON THE PATIENT WHEN THE DRIVER EXHIBITED THE SINGLE COMPRESSOR MALFUNCTION ALARM AGAIN. THE PATIENT WAS SWITCHED TO THE BACKUP COMPANION 2 DRIVER AGAIN. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454162 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR