BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, US, EP

    MDR report key: 14678503 · Received June 13, 2022

    Report

    Report Number
    2916596-2022-11558
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    November 27, 2020
    Report Date
    June 13, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010630
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF THE SYSTEM CONTROLLER SERIAL NUMBER (B)(4), RETURNED FOLLOWING A ROUTINE HEART TRANSPLANT, REVEALED INNER CONDUCTORS BREAKDOWN. THE INNER CONDUCTORS BREAKDOWN DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE A TEST PUMP DURING ANALYSIS AND DID NOT RESULT IN ANY ATYPICAL ALARM. THE DATA LOG FILE WAS SUCCESSFULLY RETRIEVED AND CONTAINED EVENTS RECORDED FROM THE TIME STAMP OF DAY 1312, 23 HOURS AND 49 MINUTES TO DAY 1321, 1 HOUR AND 36 MINUTES WHERE ROUTINE POWER CABLE DISCONNECT ALARMS WERE RECORDED. THE LAST RECORDED ENTRIES REVEALED NUMERUS ACTIVE ALARMS CONSISTENT WITH THE TRANSPLANT PROCEDURE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE CONTROLLER WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING OR QA SPECIFICATIONS. PATIENT HANDBOOK (REV. D) AND OPERATING MANUAL (REV. F) COVER ALL ALARMS (VISUAL AND AUDIBLE) ON THE SYSTEM CONTROLLER AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR. IMPORTANT WARNINGS RELATING TO PUMP STOPS ARE DESCRIBED IN OPERATING MANUAL (REV. F). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE EVALUATION THAT THE A RECENTLY TRANSPLANTED PATIENT'S SYSTEM CONTROLLER HAD INNER CONDUCTOR BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688554 HEARTMATE II SYSTEM CONTROLLER, US, EP VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 103696 00813024010630

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male