BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 13384711 · Received January 28, 2022

    Report

    Report Number
    2916596-2022-00341
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 13, 2022
    Report Date
    April 12, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CONNECTION DIFFICULTY BETWEEN THE MODULAR CABLE AND PUMP CABLE AT THE INLINE CONNECTOR COULD NOT BE CONFIRMED THROUGH THIS EVALUATION AS THE PUMP WAS NOT RETURNED FOR EVALUATION AND REMAINS IN USE. A DIRECT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT REPORTED THAT DURING SURGICAL PREPARATION THE MODULAR CABLE WAS DIFFICULT TO CONNECT TO THE PUMP CABLE AND FELT DIFFERENT FROM PREVIOUS EXPERIENCE. THE MODULAR CABLE WAS CONNECTED AFTER FIVE ATTEMPTS. THE PATIENT WAS IMPLANTED WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , ON (B)(6) 2022. THERE WERE REPORTEDLY NO ALARMS ASSOCIATED WITH THE REPORTED CONNECTION DIFFICULTY. THE MODULAR CABLE REMAINS IN USE AND THE PATIENT REMAINS ONGOING ON LVAS SUPPORT WITH NO FURTHER ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MODULAR CABLE LOT NUMBER 8140088 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (HM3 LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE IFU CONTAINS INSTRUCTIONS FOR OBSERVING DAMAGE TO THE MODULAR CABLE AND REPLACING THE MODULAR CABLE IN THE SYSTEM OPERATIONS SECTION. THE INSTRUCTIONS STATE THAT THE LOCKING NUT MUST BE ROTATED UNTIL THE CLICKING STOPS AND THE YELLOW LINE IS HIDDEN. THE SURGICAL PROCEDURES SECTION PROVIDES INSTRUCTIONS FOR CONNECTING THE MODULAR CABLE TO THE PUMP CABLE UNDER ¿PREPARING, RUNNING, AND PRIMING THE PUMP.¿ AFTER SECURING THE CONNECTION, THE YELLOW LINE SHOULD BE FULLY COVERED TO ENSURE A SECURE CONNECTION. THE DAILY SAFETY CHECKLIST INCLUDES LINE ITEMS TO ENSURE THAT THE MODULAR IN-LINE CONNECTOR IS SECURE AND THE CONNECTOR LOCKING NUT IS IN THE LOCKED POSITION. ENSURE NO YELLOW INDICATOR IS SEEN UNDER THE IN-LINE LOCKING NUT. THE IFU ALSO WARNS THAT A COMPLETE BACKUP SYSTEM MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. NO FURTHER INFORMATION PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE HEARTMATE 3 (HM3) PUMP PREP, THE MODULAR CABLE "WAS EXTREMELY HARD TO CONNECT AND IT FELT DIFFERENT FROM OTHER TIMES". THE DIFFICULTY TO CONNECT WAS BETWEEN THE MODULAR CABLE AND THE PUMP PERCUTANEOUS LEAD. IT WAS ABLE TO BE CONNECTED AFTER 5 ATTEMPTS. RELATED MANUFACTURER'S REFERENCE NUMBER FOR THE PUMP SIDE OF THE CONNECTION: 2916596-2022-00507.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43108 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525US 8140088 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male