BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 7965915 · Received October 15, 2018

    Report

    Report Number
    3003761017-2018-00483
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    October 1, 2018
    Report Date
    July 17, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRIVER PASSED ALL SECTIONS OF FUNCTIONAL TESTING. ADDITIONALLY, AN EXTENDED OBSERVATION RUN WAS PERFORMED ON THE DRIVER AND IT PERFORMED AS INTENDED WITH NO ALARMS OR ISSUES IN RELATION TO THE FILL VOLUMES THAT WOULD INDICATE A DEVICE MALFUNCTION. THE CUSTOMER DID NOT REPORT ANY DATA FROM THE TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TO BE COMPARED AGAINST THE DRIVER. THE PATIENT FILE REVIEW SHOWED 11 INSTANCES OF FILL VOLUME HIGH ALARMS, HOWEVER THESE ARE MORE A REPRESENTATION OF THE PATIENT CONDITION AT THE TIME OF THE ALARMS AND NOT INDICATIVE OF A DEVICE MALFUNCTION. THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL (C2-900005) HAS THE FOLLOWING CORRECTIVE ACTION FOR LEFT FILL VOLUME HIGH ALARMS: VERIFY DRIVER SETTINGS ARE ACHIEVING FULL EJECT/PARTIAL FILL CONDITIONS FROM DRIVER DISPLAYED WAVE FORMS, ASSESS PATIENT CONDITIONS THAT MAY CONTRIBUTE TO A LEFT FILL VOLUME HIGH ALARM. IF ALARM PERSISTS, CERTIFIED CLINICAL STAFF MAY MAKE ADJUSTMENT TO DEVICE. THE DRIVER PERFORMED AS INTENDED AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. 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.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE THE DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER MEASURES AIR TO PROVIDE AN ESTIMATE OF THE BLOOD FLOW IN THE FORM OF A FILL VOLUME NUMBER. TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) MEASURES THE ACTUAL BLOOD FLOW. THE COMPANION 2 DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. CE (B)(4) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER'S FILL VOLUMES WERE NOT COINCIDING WITH TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO A BACKUP DRIVER AND THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807910 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR