BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 20515580 · Received October 23, 2024

    Report

    Report Number
    2916596-2024-06739
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    October 4, 2024
    Report Date
    December 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE ON THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) EXPOSING INNER WIRES WAS CONFIRMED VIA ANALYSIS OF RETURNED PRODUCT. THE CONTROLLER WAS RETURNED WITH EXTENSIVE OUTER JACKET DAMAGE TO THE WHITE POWER CABLE EXPOSING INNER WIRES AS WELL GREEN FLUID, INDICATIVE OF FLUID INGRESS, NEAR THE DAMAGE. THE INNER WIRES WERE INSPECTED AND FOUND TO BE INTACT. THE SYSTEM CONTROLLER UNDERWENT PRELIMINARY AND FUNCTIONAL TESTING AND PASSED. THE SYSTEM CONTROLLER WAS CONNECTED TO A MOCK CIRCULATORY LOOP AND WAS ABLE TO OPERATE A PUMP WITHOUT ISSUE FOR EXTENDED OPERATION. SUBMITTED AND DOWNLOADED LOG FILES WERE REVIEWED AND REVEALED TYPICAL ACTIVITY. NO NOTABLE ALARMS WERE OBSERVED. THE PUMP FUNCTIONED AS INTENDED THROUGHOUT THE LOG FILES. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THE SYSTEM CONTROLLER (SERIAL #: HSC-090377) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK SECTION 5, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, AND HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, COVER ALL ALARMS (VISUAL AND AUDIBLE) AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 INSTRUCTIONS FOR USE AND HEARTMATE 3 PATIENT HANDBOOK SECTION 3, ENTITLED ¿POWERING THE SYSTEM¿, EXPLAIN THE VARIOUS WAYS TO POWER THE HEARTMATE 3 LVAS, AND HOW TO PROPERLY EXCHANGE POWER SOURCES. IT ALSO STATES THAT AT LEAST ONE SYSTEM CONTROLLER POWER CABLE MUST BE CONNECTED TO A POWER SOURCE AT ALL TIMES AND INFORMS THE USER NOT TO RELY ON THE CONTROLLER¿S BACKUP BATTERY, AS IT WILL ONLY POWER THE PUMP FOR A LIMITED AMOUNT OF TIME AND THE PUMP WILL STOP. IN ADDITION, IT STATES DO NOT USE BATTERIES TO POWER THE SYSTEM WHEN THE PATIENT IS SLEEPING. THE PATIENT MUST ALWAYS CONNECT TO THE POWER MODULE OR MOBILE POWER UNIT FOR SLEEPING OR WHEN THERE IS A CHANCE OF SLEEP. A SLEEPING PATIENT MAY NOT HEAR THE SYSTEM CONTROLLER ALARMS. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8, ENTITLED ¿EQUIPMENT STORAGE AND CARE¿, AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6, ENTITLED ¿CARING FOR EQUIPMENT¿, EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT, INCLUDING THE CONTROLLER AND THE POWER CABLES. 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 AND MAINTAIN THE EQUIPMENT FOR PROPER USE INCLUDING HOW TO ENSURE THAT THE CONTROLLERS AND EQUIPMENT DO NOT GET WET. HEARTMATE 3 PATIENT HANDBOOK 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. 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 PATIENT REQUIRED A NON-EMERGENT SYSTEM CONTROLLER AND MODULAR CABLE EXCHANGE ON (B)(6) 2024 IN THE VENTRICULAR ASSIST DEVICE (VAD) CLINIC. THE MODULAR CABLE WAS REPORTED TO HAVE KINKS IN IT AND THERE WERE EXPOSED WIRES ON THE CONTROLLER. THE PATIENT WAS ASYMPTOMATIC PRIOR TO AND POST DEVICE EXCHANGE. THERE WERE NO ALARMS NOTED ON INTERROGATION IN CLINIC. THE PATIENT REQUIRED NO OTHER INTERVENTIONS AND WAS SENT HOME. LOG FILES SENT FOR REVIEW CAPTURED ROUTINE EVENTS, THERE WERE NO NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19366 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7740578 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male