BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 19430738 · Received May 30, 2024

    Report

    Report Number
    2916596-2024-03212
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 22, 2024
    Report Date
    August 30, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION H6: HEALTH EFFECT - IMPACT CODE AND MEDICAL DEVICE PROBLEM CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGED MODULAR CABLE WAS CONFIRMED WITH THE PROVIDED PHOTO. THE CUSTOMER PROVIDED REFERENCE PHOTO CAPTURED THE DAMAGED MODULAR CABLE WITH EXPOSED WIRES. THE WIRES APPEARED TO BE SOLDERED. IT WAS REPORTED THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND THE DAMAGED MODULAR CABLE WAS REPAIRED BY SOLDERING THE WIRES. THE SYSTEM CONTROLLER WAS EXCHANGED TO A DEMO SYSTEM CONTROLLER AND THE PUMP STARTED. BOTH THE DEMO SYSTEM CONTROLLER AND DAMAGED MODULAR CABLE WERE REPLACED. ADDITIONAL INFORMATION REPORTED THE MODULAR CABLE WAS DAMAGED USING A SAW AND THE PATIENT IS DOING FINE. IT WAS REPORTED MODULAR CABLE (LOT # 7718708) WILL NOT BE RETURNED FOR EVALUATION. DEVICE HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO MFG AND QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK (REV G) AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV G) ARE CURRENTLY AVAILABLE. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS SECTION FURTHER CAUTIONS: ¿DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, THE POWER MODULE PATIENT CABLE, OR THE MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LVAS TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN.¿ THIS SECTION ALSO INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS AND URGES PATIENTS TO INFORM THEIR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿. SECTION 8, ¿EQUIPMENT STORAGE AND CARE¿, ALSO CONTAINS INFORMATION ON ¿CARE OF THE DRIVELINE,¿ AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE. IN THE PATIENT HANDBOOK, SECTION 4, ¿LIVING WITH THE HEARTMATE III¿, CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. SECTION 5, ¿ALARMS AND TROUBLESHOOTING¿, CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    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

    IT WAS REPORTED THAT THE PATIENT CUT THEIR MODULAR CABLE ON (B)(6) 2024 AND THE PUMP STOPPED AND A DRIVELINE DISCONNECT ALARM OCCURRED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND THEY WERE STABILIZED WITH INOTROPES AND HEPARINE. THE PATIENT'S HEMODYNAMIC SITUATION IMPROVED FOLLOWING TREATMENT. THE PHYSICIAN REPAIRED THE MODULAR CABLE BY SOLDERING THE WIRES. A DEMO SYSTEM CONTROLLER WAS TAKEN AFTER THE REPAIR TO THE PUMP STARTED AGAIN. THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED. THE PATIENT REMAINED STABLE WITH NO INJURIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ACCIDENTALLY CUT THEIR MODULAR CABLE WITH A SAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275088 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 7718708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other