BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 6973010 · Received October 24, 2017

    Report

    Report Number
    3003761017-2017-00195
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 24, 2017
    Report Date
    February 26, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SYNCARDIA CLINICAL SPECIALIST HAS DISCUSSED AND RETRAINED HOSPITAL STAFF ON THE COMPANION 2 DRIVER IN REFERENCE TO THE 50CC TAH-T, AND THAT THE COMPANION 2 DRIVER DOES NOT ALERT THE STAFF OF HIGH FILL VOLUMES FOR THE 50CC TAH-T. 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

    THE COMPANION 2 DRIVER IS NOT BEING RETURNED TO SYNCARDIA FOR EVALUATION AS THERE IS NO DEVICE MALFUNCTION. THE DRIVER PERFORMED AS INTENDED. COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL, SECTION 8.2.5 OPTIMIZATION OF ADJUSTMENTS CONTAINS A CAUTION STATEMENT INDICATING THAT THE LEFT AND RIGHT FILL VOLUME HIGH ALARMS WILL NOT OCCUR WHEN THE COMPANION 2 DRIVER IS BEING USED WITH THE 50 CC TAH-T. FURTHER, THE CAUTION STATEMENT INDICATES THAT THE FILL VOLUMES FOR THE 50 CC TAH-T SHOULD BE MONITORED AND DRIVER SETTINGS ADJUSTED IF THE PATIENT IS EXPERIENCING OR APPROACHING A FULL FILL CONDITION GREATER THAN 40 CC. THE MANUAL STATES THAT FOR A 50 CC PATIENT, ACCEPTABLE FILL VOLUMES SHOULD BE BETWEEN 30 CC AND 40 CC. COMPANION 2 DRIVER SYSTEM TRAINING PRESENTATION, SLIDE 30, STATES "THE LEFT/RIGHT FILL VOLUME HIGH ALARMS ARE DESIGNED TO TRIGGER WHEN FILL VOLUME EXCEEDS 65 ML AND THEREFORE WILL NOT OCCUR WHEN THE COMPANION 2 DRIVER IS BEING USED WITH THE 50 CC TAH-T". IN ADDITION, SLIDE 30 OF THE PRESENTATION STATES "50 CC TAH-T FILL VOLUMES SHOULD BE MONITORED AND DRIVER SETTINGS MAY BE ADJUSTED IF THE PATIENT IS EXPERIENCING OR APPROACHING A FULL FILLING CONDITION (40-50 ML)". SYNCARDIA WILL PROVIDE ADDITION INFORMATION IN A FOLLOW-UP MDR AS IT BECOMES AVAILABLE. (B)(4) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT, A 50 CC TAH-T PEDIATRIC STUDY SUBJECT, WAS INITIALLY WEANED FROM THE VENTILATOR ON (B)(6) 2017, 1 DAY POST-IMPLANT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS RE-INTUBATED AFTER HAVING A PULMONARY EPISODE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS AGAIN EXTUBATED ON (B)(6) 2017. THE CUSTOMER EXPRESSED CONCERN THAT THERE ARE NO HIGH FILL VOLUME ALARMS ON THE COMPANION 2 DRIVER TO ALERT THE STAFF OF THE SUBJECT'S HIGH FILL VOLUMES ON 50 CC TAH-T SUPPORT. IT WAS REPORTED THAT THE LACK OF THIS ALARM WAS SEEN TO HAVE POSSIBLY CONTRIBUTED TO THE PULMONARY EDEMA AND RE-INTUBATION THAT WAS EXPERIENCED BY THE SUBJECT. THE STAFF INDICATED THAT AN ALARM MAY HAVE ALERTED THE STAFF PRIOR TO THE SUBJECT'S FULL FILLING OF THE 50 CC TAH-T. THE CUSTOMER ALSO REPORTED THAT THE PATIENT REMAINS ON COMPANION 2 DRIVER S/N (B)(4) SINCE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750970 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention