BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 12673425 · Received October 21, 2021

    Report

    Report Number
    3003761017-2021-00199
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 28, 2021
    Report Date
    September 30, 2022
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003107
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT DATA FILE WAS REVIEWED AND SHOWED THAT DRIVER WAS PUT ON PATIENT SUPPORT ON (B)(6) 2021 AT 0209. THE DRIVER RAN FOR 42 DAYS UNTIL ON (B)(6) 2021 AT 1036 WHEN PATIENT WAS SWITCHED TO A DIFFERENT DRIVER. DURING THIS TIME FRAME THERE WERE NO RECORDED ALARMS THAT WOULD INDICATE A DEVICE MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE PATIENT HEMOLYSIS. DURING REVIEW OF THE PATIENT FILE DATA, IT WAS ALSO POSSIBLE TO GRAPH OUT WHAT THE PRESSURE AND FLOW WAVEFORMS WOULD HAVE LOOKED LIKE ON THE COMPANION 2 DRIVER DISPLAY DURING PATIENT USE. THE PRESSURE AND FLOW WAVEFORMS OF THE FIRST AND LAST HOURS OF PATIENT USE WERE REVIEWED AND SHOWED NO EVIDENCE OF A DEVICE MALFUNCTION. DURING FUNCTIONAL TESTING, THE DRIVER PASSED ALL TEST STEPS. THE DRIVER WAS FURTHER SUBJECTED TO AN ADDITIONAL 48-HOUR OBSERVATION RUN IN AN ATTEMPT TO OBSERVE A POSSIBLE MALFUNCTION OR CHANGE IN DRIVER PERFORMANCE. THE DRIVER PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CUSTOMER-REPORTED PATIENT HEMOLYSIS CAUSED BY A POSSIBLE DEVICE MALFUNCTION WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE CUSTOMER-REPORTED PATIENT HEMOLYSIS COULD NOT BE DETERMINED. SYNCARDIA IS AWARE THAT ALL MECHANICAL CIRCULATORY SUPPORT DEVICES MAY CONTRIBUTE TO HEMOLYSIS AND IS CONTINUING TO STUDY THE IMPACT OF THE TAH-T SYSTEM ON THE REPORTED EXPERIENCE. SYNCARDIA HAS COMPLETED ITS INVESTIGATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE PATIENT DEVELOPED HEMOLYSIS (LDH APPROXIMATELY 3000 U/L AND FRESH HEMOGLOBIN APPROXIMATELY 200 MG/DL) WHILE SUPPORTED BY THE COMPANION 2 DRIVER. THE CUSTOMER ALSO REPORTED THE PATIENT WAS SUBSEQUENTLY SWITCHED TO A BACKUP COMPANION 2 DRIVER AND THE LDH DECREASED AND THE FREE HEMOGLOBIN RETURNED TO NORMAL LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570843 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 397002-001 00858000003107

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Prefer Not To Disclose Required Intervention