BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 15537232 · Received October 4, 2022

    Report

    Report Number
    2916596-2022-14307
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 25, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. REPORTER POSTAL OFFICE OR ZIP CODE:(B)(6).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF ¿DAMAGE TO THE WHITE POWER CABLE¿ WAS CONFIRMED WITH THE PROVIDED REFERENCE PHOTO. THE PROVIDED REFERENCE PHOTO CAPTURED THE DAMAGE STRAIN RELIEF ON THE WHITE POWER CABLE. IT WAS NOTED THERE WAS VISIBLE GREEN/BLUE FLUID. PREVIOUS COMPLAINT HISTORY DETERMINED THE GREEN/BLUE FLUID SUBSTANCE WAS THE RESULT OF ACCUMULATED MOISTURE UNDERNEATH THE PERMEABLE OUTER GREY INSULATION THAT REACTED WITH THE UNDERLYING SHIELDING/CONSTRUCTION. REVIEW OF THE LOG FILE REVEALED THE SYSTEM OPERATED WITHIN THE PATIENT SPEED LIMIT (5,500 RPM) AND LOW SPEED LIMIT (5,300 RPM). ROUTINE POWER CABLE DISCONNECT ALARM EVENTS WERE CAPTURED RELATING TO NORMAL POWER EXCHANGES. EVENT DETAILS INDICATED THE SYSTEM CONTROLLER WAS EXCHANGED. ADDITIONAL INFORMATION COMMUNICATED ON 03OCT2022 INDICATED NO PRODUCTS ARE RETURNING FOR AN EVALUATION. A ROOT CAUSE THAT ATTRIBUTED TO THE DAMAGED STRAIN RELIEF COULD NOT BE DETERMINED DURING THE EVALUATION. DEVICE HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO MFG AND QA SPECIFICATIONS. SYSTEM CONTROLLER (SERIAL # (B)(6)) WAS SHIPPED TO THE CUSTOMER ON 02DEC2018. HEARTMATE 3 PATIENT HANDBOOK REV D, CAUTIONS THE USERS TO ¿CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. YOUR HOSPITAL CONTACT CAN CHECK THE EQUIPMENT AND ORDER REPLACEMENTS, IF NEEDED. DO NOT TRY TO REPAIR ANYTHING YOURSELF.¿ UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR. HEARTMATE 3 INSTRUCTIONS FOR USE REV C, ¿REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN¿. 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 HAD A LARGE TEAR IN THE MODULAR CABLE AND DAMAGE TO THE WHITE POWER CABLE. THE CONTROLLER AND MODULAR CABLE WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2778179 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 6673135 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male