BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 10718432 · Received October 22, 2020

    Report

    Report Number
    2916596-2020-05112
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    October 6, 2020
    Report Date
    February 9, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENTS OF A CONTROLLER FAULT ALARM, AND THE CONTROLLER NOT COMMUNICATING WITH THE SYSTEM MONITOR, WERE NOT CONFIRMED. ONE LOG FILE WITHIN THE TIMEFRAME OF THE REPORTED EVENT WAS PROVIDED AND REVIEWED. THE LOG FILE CONTAINED DATA SPANNING 8 DAYS (28SEP2020 ¿ 06OCT2020 PER TIME STAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. NO ATYPICAL ALARMS NOR ATYPICAL EVENTS RELATED TO THE SYSTEM CONTROLLER WERE OBSERVED THROUGHOUT THE LOG FILE. DATA FROM 07OCT2020 WAS UNABLE TO BE OBSERVED. THE SYSTEM CONTROLLER (SERIAL NUMBER (B)(6) WAS NOT RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS AT RETRIEVING THE CONTROLLER¿S RETURN STATUS, AS WELL AS ANOTHER LOG FILE, WERE MADE, AND NO RESPONSES WERE RECEIVED. THE ROOT CAUSES OF THE REPORTED EVENTS WERE UNABLE TO BE DETERMINED THROUGH THIS ANALYSIS. THE HEARTMATE II PATIENT HANDBOOK SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ INSTRUCTS USERS ON HOW TO RESOLVE ANY ALARMS THAT SOUND FROM THEIR SYSTEM CONTROLLER, INCLUDING ALARMS ASSOCIATED WITH CONTROLLER FAULT CONDITIONS. THE HEARTMATE II PATIENT HANDBOOK SECTION TITLED "EMERGENCY CONTACT LIST" CAUTIONS USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. REVIEW OF THE DEVICE HISTORY RECORD FOR THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE CONTROLLER WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2017. 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

    IT WAS REPORTED THAT THE PATIENT REQUIRED A CONTROLLER EXCHANGE ON (B)(6) 2020. AFTER DISCONNECTING THE PATIENT FROM THE POWER MODULE FOR TRANSPORT, THE PATIENT EXPERIENCED A CONTROLLER FAULT ALARM. AFTER ATTEMPTING TO RECONNECT THE PATIENT TO THE POWER MODULE/SYSTEM MONITOR, THE CONTROLLER WOULD NOT COMMUNICATE WITH THE SYSTEM MONITOR. THE GREEN RUNNING SYMBOL REPORTED ON THE ENTIRE TIME, BUT THE SITE WAS UNABLE TO ACCESS THE VAD PARAMETERS FROM THE CONTROLLER. THE CONTROLLER WAS EXCHANGED WITHOUT DIFFICULTY AND COMMUNICATION WAS STORED WITH THE SYSTEM MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182317 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106762 6011967

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention