BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER, US

    MDR report key: 8615892 · Received May 16, 2019

    Report

    Report Number
    2916596-2019-02235
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    May 2, 2019
    Report Date
    September 10, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4,10: ADDITIONAL INFORMATION SECTION G3: CORRECTION SECTION H3,4: ADDITIONAL INFORMATION MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF PUMP STOPS WAS CONFIRMED VIA ANALYSIS OF THE SUBMITTED LOG FILE WHICH APPEARED CONSISTENT WITH THE PUMP CABLE DAMAGE THAT WAS CONFIRMED THROUGH THE VIDEO SUBMITTED BY THE ACCOUNT. THE SUBMITTED LOG FILE CONTAINED APPROXIMATELY 8 HOURS OF DATA (02MAY2019 AT 23:45 ¿ 03MAY2019 AT 07:44, PER THE TIME STAMP). THE STORED PATIENT SPEED WAS SET TO 5400 RPM AND THE LOW SPEED LIMIT (LSL) WAS SET TO 5000 RPM. FOR THE DURATION OF THE FILE, THE PUMP SPEED WAS CAPTURED AT 0 RPM, THE CALCULATED AVERAGE FLOW WAS 0.0 LPM, AND THE MOTOR POWER WAS 0.0 MW. CONTROLLER INTERNAL FAULT, DRIVELINE POWER FAULT, LOSS OF LVAD COMMUNICATION, LOW FLOW, AND LVAD OFF ALARMS WERE ACTIVE FOR THE DURATION OF THE FILE. THE EVENTS CAPTURED IN THE LOG FILE ARE CONSISTENT WITH THE REPORT THAT THE PUMP CABLE WAS SLICED DURING A DRESSING CHANGE (REPORTED UNDER MFR# 2916596-2019-02234). ANALYSIS OF THE SECOND SUBMITTED LOG FILE SHOWED THAT IT CONTAINS DATA FROM A NEW CONTROLLER, SERIAL NUMBER HSC-061293, WHICH APPEARS CONSISTENT WITH THE ACCOUNT¿S REPORT THAT THE DRIVELINE WAS CONNECTED TO A NEW CONTROLLER ON THE DATE OF THE REPAIR. ON 03MAY2019 FROM 15:50:03 THROUGH 16:56:52, THE PUMP SPEED DID NOT DROP BELOW THE LOW SPEED LIMIT AND NO ADDITIONAL ATYPICAL ALARMS WERE CAPTURED. IT APPEARED THAT THE SYSTEM WAS OPERATING AS INTENDED AFTER SUPPORT WAS INITIALIZED FROM THE NEW CONTROLLER POST-REPAIR. THE INVESTIGATION CONFIRMED THAT THE RETURNED SYSTEM CONTROLLER (HSC-061342, BACKUP BATTERY SN: SR262450) HAD TWO DAMAGED FUSES. THE FUSES WERE REPLACED, AND THE RETURNED SYSTEM CONTROLLER PASSED FUNCTIONAL TESTING USING LABORATORY TEST EQUIPMENT AND WAS ABLE TO SUPPORT A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD OF TIME, WITHOUT ANY ATYPICAL ALARMS OR EVENTS BEING CAPTURED. EVALUATION OF THE SUBMITTED VIDEO CONFIRMED A CUT TO THE PUMP CABLE NEAR THE DRIVELINE EXIT SITE. THE OUTER SILICONE LAYER, UNDERLYING ARMOR LAYER, AND BIONATE WERE ALL DAMAGED. THE UNDERLYING BROWN, BLACK, AND RED WIRES WERE SEVERED IN THIS LOCATION. THE FRACTURE OF THESE WIRES WOULD HAVE CAUSED THE OBSERVED PUMP STOP EVENT (REPORTED UNDER MFR# 2916596-2019-02234). THEREFORE, ANALYSIS OF THE RETURNED SYSTEM CONTROLLER AND THE PROVIDED INFORMATION INDICATED THAT THE ROOT CAUSE FOR THE PUMP STOP EVENT WAS RELATED TO THE COMPROMISED WIRES NOTED IN THE PUMP CABLE CONFIRMED VIA THE SUBMITTED VIDEO. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 9 MONTHS (THE AGE IS CALCULATED FROM THE DATE OF IMPLANT TO THE EVENT DATE.). THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT HAD A LOW FLOW ALARM. UPON ARRIVAL AT THE EMERGENCY ROOM, THE PUMP WAS DETERMINED TO NOT BE RUNNING. THE SITE INDICATED THAT THERE WAS A SLICE IN THE PERCUTANEOUS PORTION OF THE DRIVELINE, WHICH WAS CAUSED WHEN THE PATIENT. THE LOG FILE ANALYSIS CONFIRMED THAT THE PUMP WAS NO LONGER OPERATIONAL AND THAT BOTH CONTROLLER FUSES WERE OPEN. THE SITE HAS STARTED THE PATIENT ON HEPARIN. SITE HAS REQUESTED A REPAIR OF THE DRIVELINE TO TURN THE PUMP BACK ON. DUE TO NO DRIVELINE REPAIR KIT AVAILABLE, CLINICAL PROVIDED GUIDANCE TO THE SITE ON HOW TO ISOLATE THE WIRES TO PREVENT FROM RE-SHORTING. PER CUSTOMER, A REPAIR WAS PERFORMED. IT WAS INDICATED VIA TEXT THAT THE BROWN, RED AND BLACK WIRES WERE TOUCHING EACH OTHER BUT OTHER THAN THE COMPRISED INSULATION, THE WIRES WERE NOT DAMAGED. THE WIRES WERE WRAPPED INDIVIDUALLY WITH TAPE AND THEN WRAPPED THE BUNDLE. THE CABLE WAS CONNECTED TO A NEW CONTROLLER AND THE PUMP WAS RESTARTED, APPROXIMATELY 16 HOURS AFTER INITIAL EVENT. PER CUSTOMER, THE PATIENT WAS DOING WELL AND THE REPAIR WAS THOUGHT TO LAST UNTIL TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410352 HEARTMATE 3 SYSTEM CONTROLLER, US LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 106531US

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention