BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, US, EP

    MDR report key: 10180994 · Received June 22, 2020

    Report

    Report Number
    2916596-2020-03057
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 25, 2020
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10, G3, H5, H8: CORRECTION. SECTION D4, H3, H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE SYSTEM CONTROLLER SERIAL NUMBER (B)(6), RETURNED FOR EVALUATION, WAS FUNCTIONALLY TESTED USING THE LABORATORY EQUIPMENT AND AN EARLY STAGE OF CONDUCTOR BREAKDOWN IN BOTH POWER CABLES WAS CONFIRMED. THE EARLY STAGE OF CONDUCTOR BREAKDOWN DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE A TEST PUMP DURING ANALYSIS. THE ROOT CAUSE OF THE INNER CONDUCTOR BREAKDOWN APPEARED TO BE RELATED TO WEAR AND TEAR DUE TO REPETITIVE LEAD FLEXING DURING CABLE USE. THE DATA LOG FILE WAS SUCCESSFULLY RETRIEVED AND CONTAINED EVENTS RECORDED FROM THE TIME STAMP OF DAY 1315, 23 HOURS AND 43 MINUTES TO DAY 1322, 20 HOURS AND 19 MINUTES WHERE POWER CABLE DISCONNECT ALARMS WERE RECORDED. THE SYSTEM MAINTAINED THE DESIRED SET SPEED WITH NO INTERRUPTIONS. PERIODICALLY INSPECTING THE EQUIPMENT FOR DAMAGE IS COVERED IN THE PATIENT HANDBOOK. GENERAL CARE AND GUIDELINES OF THE SYSTEM CONTROLLER ARE DESCRIBED IN PATIENT HANDBOOK AND OPERATING MANUAL. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE INVESTIGATION OF THE RETURNED SYSTEM CONTROLLER SERIAL NUMBER (B)(4) REVEALED AN EARLY STAGE OF CONDUCTOR BREAKDOWN IN BOTH POWER CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646434 HEARTMATE II SYSTEM CONTROLLER, US, EP VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103696 00813024010630

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR