BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 10885861 · Received November 23, 2020

    Report

    Report Number
    2916596-2020-05444
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    October 26, 2020
    Report Date
    March 3, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT (INCLUDING DEVICE SERIAL NUMBER); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A CONTROLLER FAULT ALARM COULD NOT BE CONFIRMED THROUGH THIS LIMITED EVALUATION. ACCORDING TO EVENT DETAILS, THE SYSTEM CONTROLLER DISPLAYED A CONTROLLER FAULT WITH A YELLOW WRENCH AND A HALF LIT GREEN POWER LIGHT. IT WAS NOTED THAT COMMUNICATION TO THE SYSTEM MONITOR WAS UNABLE TO BE ESTABLISHED. THIS SUGGESTS THE SYSTEM CONTROLLER IS OPERATING IN THE BACKUP MODE. THE SYSTEM CONTROLLER WAS NOT EXCHANGED AT THE TIME DUE TO A POTENTIAL ISSUE WITH THE PUMP NOT RESTARTING. A ROOT CAUSE COULD NOT BE DETERMINED THROUGH THIS EVALUATION. ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. ALL AVAILABLE INFORMATION FOR CONDUCTING THIS INVESTIGATION WAS COLLECTED AND NO ADDITIONAL FOLLOW-UP ATTEMPTS WILL BE PERFORMED. TO DATE, THE SYSTEM CONTROLLER (SERIAL # UNAVAILABLE) ASSOCIATED WITH THE EVENT WAS UNAVAILABLE FOR AN EVALUATION. THE COMPLAINT FILE WILL CLOSE ACCORDINGLY AND WILL BE REOPENED IF ADDITIONAL PERTINENT INFORMATION IS RECEIVED. SERIAL NUMBER WAS UNAVAILABLE, AND THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HEARTMATE II LVAS IFU, SECTION 7 AND HEARTMATE II PATIENT HANDBOOK SECTION 5, UNDER ALARMS AND TROUBLESHOOTING, DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR. THIS INCLUDES THE DRIVELINE FAULT ALARM. HEARTMATE II LVAS IFU SECTION 2, HEARTMATE II PATIENT HANDBOOK SECTION 2, COVERS REPLACING THE RUNNING SYSTEM CONTROLLER WITH A BACKUP CONTROLLER. HEARTMATE II LVAS IFU, HEARTMATE II PATIENT HANDBOOK, BOTH OF WHICH CAUTIONS THE 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER WAS NOT PROVIDED THEREFORE UDI IS NOT AVAILABLE. HISTORY OF PHASE TO PHASE REPORTED IN MFR# 2916596-2019-05144. 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'S CONTROLLER WAS DISPLAYING A CONTROLLER FAULT WITH A YELLOW WRENCH. IT WAS REPORTED THAT PATIENT HAS A HISTORY OF PHASE TO PHASE. WHEN THE PATIENT WAS CONNECTED TO THE SYSTEM MONITOR NO PARAMETERS DISPLAYED. ALSO TO NOTE, HALF THE GREEN POWER LIGHT ON THE CONTROLLER WAS ILLUMINATED. WITH THE REPORTED DETAILS IT WAS EXPLAINED THAT THE CONTROLLER HAS FAULTED, AND WAS RUNNING ON THE BACKUP SYSTEM. IT WAS ADVISED THAT CONTROLLER WOULD NEED TO BE EXCHANGED TO RESOLVE THE CONTROLLER FAULT ALARM. AFTER DISCUSSION, THE TEAM OPTED NOT EXCHANGE THE CONTROLLER DUE TO FEAR THAT PUMP MAY NOT RESTART, DUE TO THE PHASE TO PHASE. IT WAS REPORTED THE PATIENT WAS GOING TO HOSPICE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352600 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106762

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR