BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 15018803 · Received July 14, 2022

    Report

    Report Number
    2916596-2022-12278
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    July 12, 2022
    Report Date
    September 6, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF LEDS NOT ILLUMINATING ON THE SYSTEM CONTROLLER WAS CONFIRMED. THE SYSTEM CONTROLLER (SERIAL #: HSC-010477) WAS RETURNED FOR ANALYSIS AND UNDERWENT PRELIMINARY AND FUNCTIONAL TESTING. THE CONTROLLER DID NOT PASS THE SELF-TEST DUE TO SOME LEDS NOT LIGHTING UP AS INTENDED. WHEN ALARMS WERE PROMPTED, THE ALARMS WERE UNABLE TO BE SILENCED. THE SYSTEM CONTROLLER UNDERWENT TROUBLESHOOTING. IT WAS FOUND THAT REPLACING THE TOP HOUSING/USER INTERFACE (UI) WITH A FUNCTIONING TEST TOP HOUSING/UI RESOLVED THE EVENT. THE SYSTEM CONTROLLER THEN UNDERWENT FUNCTIONAL TESTING AND EXTENDED OPERATION WITH THE FUNCTIONING TOP HOUSING/UI AND WAS ABLE TO OPERATE FOR AN EXTENDED OPERATION AS INTENDED. FURTHER TROUBLESHOOTING ENSUED, AND IT WAS FOUND THAT THE UI RIBBON CONNECTOR, J1, WAS LOOSE WHICH CAUSED THE LACK OF LEDS LIT UP ON THE SYSTEM CONTROLLER AND THE ALARM SILENCE BUTTON TO NOT FUNCTION AS INTENDED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE DUE TO DAMAGE TO J1 ON THE UI; HOWEVER, A FURTHER ROOT CAUSE FOR THE DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DURING THE INVESTIGATION THERE WAS AN INCIDENTAL FINDING OF FLUID INGRESS. THE DUAL POWER LEADS OF THE SYSTEM CONTROLLER WERE STRIPPED, AND GREEN FLUID INGRESS WAS OBSERVED. THERE WAS NO DAMAGE TO THE UNDERLYING WIRES. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL #: HSC-010477) AND THE SYSTEM CONTROLLER PASSED ALL MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE III INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS. HEARTMATE III INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. 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

    IT WAS REPORTED THAT THE LED LIGHTS FOR THE PUMP RUNNING SYMBOL AND THE BATTERY CHARGE LEVELS ON THE PATIENT'S SYSTEM CONTROLLER DID NOT ILLUMINATE. THE SYSTEM CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061264 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531INT 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 Male