BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 12027122 · Received June 18, 2021

    Report

    Report Number
    2916596-2021-03176
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 24, 2021
    Report Date
    September 28, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAIN INVESTIGATION CONCLUSION THE HEARTMATE II SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) IS BEING EVALUATED FOR THE REPORTED EVENT OF PUMP STOPS. THE SYSTEM CONTROLLER WAS NOT RETURNED FOR ANALYSIS; HOWEVER, LOG FILES WERE SUBMITTED FOR REVIEW. A REVIEW OF THE LOG FILES SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 24 DAYS ((B)(6) 2017, (B)(6) 2021 PER TIMESTAMP). ON (B)(6) 2021 FROM 11:59:39 ¿ 12:11:08 AND LOW PUMP SPEEDS AND PUMP STOPS WERE CAPTURED FROM 12:11:07 ¿ 12:11:11. THESE ALARMS WERE CLEARED WHEN THE DRIVELINE WAS DISCONNECTED AT 12:11:09 AND RECONNECTED AT 12:11:11. THERE WERE NO NOTABLE ALARMS ACTIVE RELATED TO SYSTEM CONTROLLER FUNCTION AND THE REPORTED EVENT WAS UNABLE TO BE CORRELATED TO AN ISSUE WITH THE SYSTEM CONTROLLER. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) AND WAS FOUND TO PASS ALL MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. HEARTMATE II INSTRUCTIONS FOR USE, REV. C, SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II PATIENT HANDBOOK, REV. C, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING LOW FLOW HAZARD, PUMP STOP AND DRIVELINE FAULT ALARMS. THE HEARTMATE II PATIENT HANDBOOK, REV. C, SECTION 8 ¿HANDLING EMERGENCIES¿ INSTRUCTS USERS ON HOW TO HANDLE EMERGENCIES, INCLUDING SITUATIONS WHERE THE PUMP HAS STOPPED. IF THE OUTLINED TROUBLESHOOTING STEPS DO NOT RESOLVE THE ISSUE, CONTACT EMERGENCY SERVICES IMMEDIATELY. THE PATIENT HANDBOOK 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.

    Description of Event or Problem · 0

    RELATED MFR # 2916596-2021-02996. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD BEEN SWITCHED TO CONTROLLER (B)(6). AFTER THE DRIVELINE REPAIR. THERE WERE NO REPORTED ISSUES WITH CONTROLLER (B)(6).

    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 WAS IN CLINIC AND HAD MULTIPLE PUMP STOPS ALARMS OVER THE FEW DAYS PRIOR. A REVIEW OF THE LOGFILES REVEALED 31 PUMP STOPS AND 32 LOW SPEED ADVISORIES ON (B)(6) 2021, BETWEEN 0422 ¿ 0428 AS WELL AS ON (B)(6) 2021 041. THIS TYPE OF BEHAVIOR HAS BEEN LINKED TO POTENTIAL ISSUES WITH THE PERCUTANEOUS LEAD. THESE ISSUES ONLY APPEARED WHILE THE VENTRICULAR ASSIST DEVICE (VAD) IS CONNECTED TO THE POWER MODULE. IN ORDER TO PREVENT FURTHER INTERRUPTION IN SUPPORT, IT MAY BE BENEFICIAL TO KEEP THE VAD CONNECTED TO BATTERY POWER OR AN UNGROUNDED CABLE UNTIL FURTHER INVESTIGATION IS COMPLETED. TO IDENTIFY A POSSIBLE LOCATION OF WHERE THE COMPROMISE IN THE LEAD IS, X-RAYS WILL BE NEEDED. THESE X-RAYS SHOULD SHOW THE ENTIRE PERCUTANEOUS LEAD FROM ITS CONNECTION TO THE CONTROLLER TO WHERE IT ATTACHES TO THE VAD WITH AS FEW TWIST/TURNS TO THE DRIVELINE AS POSSIBLE. ANY OTHER INFORMATION SUCH AS IF THE PERCUTANEOUS LEAD WAS EXPOSED TO ANY TRAUMA, IF THE PATIENT HAS GAINED OR LOST A SIGNIFICANT AMOUNT OF WEIGHT, OR IF SPECIFIC PATIENT TORSO MOVEMENTS CAUSED ALARMS WILL BE HELPFUL IN POSSIBLY IDENTIFYING THE AREA OF CONCERN. IN ADDITION, PATIENT STATUS WAS REQUESTED TO DETERMINE IF THEY WERE SYMPTOMATIC. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE MCS EQUIPMENT IS OPERATING AS INTENDED. ADDITIONAL INFORMATION REVEALS A DRIVELINE REPAIR AND CONTROLLER EXCHANGE OCCURRED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921189 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR