BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17231251 · Received June 29, 2023

    Report

    Report Number
    2916596-2023-04367
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 20, 2023
    Report Date
    November 7, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS WAS ABLE TO BE CONFIRMED. THE MODULAR CABLE (LOT NUMBER: 183276) WAS RETURNED FOR ANALYSIS. THE MODULAR CABLE WAS CONNECTED TO THE MANUFACTURING TEST AND DID NOT PASS. THE MODULAR CABLE WAS CONNECTED AND FUNCTIONALLY TESTED WITH A TEST HEARTMATE 3 SYSTEM CONTROLLER IN THE LABS AT ABBOTT AND DRIVELINE POWER FAULT ALARMS ACTIVATED. THE MODULAR CABLE WAS STRIPPED TO INSPECT THE CONDITION OF THE UNDERLYING LAYERS, AND MULTIPLE WIRES WERE FOUND TO BE DAMAGED. NO FURTHER TESTING WAS CONDUCTED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2023 STATED THAT THERE WERE NO PATIENT CONSEQUENCES, AND THAT THE ALARMS RESOLVED FOLLOWING THE EXCHANGE. THE ROOT CAUSE OF THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE CAUSED BY DAMAGED WIRES. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MODULAR CABLE (LOT NUMBER: 183276) AND WAS FOUND TO PASS ALL MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. HEARTMATE III INSTRUCTIONS FOR USE SECTION 2 ENTITLED ¿SYSTEM OPERATIONS¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 2 ENTITLED ¿HOW YOUR HEART PUMP WORKS¿ STATES ¿DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, POWER MODULE PATIENT CABLE, OR MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE.¿ 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'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBERS: 2916596-2023-04366 AND 2916596-2023-07089.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN OUTPATIENT FOLLOW-UP VISIT, ON (B)(6) 2023, A DRIVELINE POWER FAULT OCCURRED. THE MODULAR CABLE WAS EXCHANGED AS TREATMENT FOR THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265078 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 183276 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown