BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 19962171 · Received August 12, 2024

    Report

    Report Number
    2916596-2024-05068
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 19, 2024
    Report Date
    October 18, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED THE DRIVELINE COMMUNICATION FAULT ALARMS THAT REPORTEDLY RESOLVED WITH A MODULAR CABLE AND CONTROLLER EXCHANGE; HOWEVER, A SPECIFIC CAUSE FOR THESE ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A COMMUNICATION FAULT ALARM. IT WAS NOTED THAT THE DRIVELINE HAD BEEN RESCUE TAPED FOR SOME DAMAGE; HOWEVER, DAMAGE COULD NOT BE CONFIRMED AS NO PRODUCT WAS RETURNED AND NO PHOTOS WERE SUBMITTED FOR REVIEW. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED, RESOLVING THE FAULT. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS ON 19JUL2024 FROM 14:07:18 TO 15:04:09, PER THE TIMESTAMPS. A DRIVELINE COMMUNICATION FAULT ALARM WAS ACTIVE FOR THE DURATION OF THE LOG FILE. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED FOR THE DURATION OF THE FILE. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SUPPORT WITH NO FURTHER COMPLAINTS REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD FOR MODULAR CABLE, LOT NUMBER 7221683, WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, 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 LVAD TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN." SECTION 6 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, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INSTRUCTION REGARDING HOW TO CARE FOR THE DRIVELINE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." SECTION 7 ALSO OUTLINES SYSTEM CONTROLLER ALARMS, INCLUDING THE COMMUNICATION FAULT ALARM, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8, ¿EQUIPMENT STORAGE AND CARE¿, ALSO CONTAINS INFORMATION ON ¿CARE OF THE DRIVELINE,¿ AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE. SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, CONTAINS A SUBSECTION ENTITLED ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿ WHICH CONTAINS INFORMATION REGARDING HOW TO CARE FOR THE DRIVELINE. SECTION 5 ALSO OUTLINES SYSTEM CONTROLLER ALARMS, INCLUDING THE COMMUNICATION FAULT ALARM, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8 ENTITLED ¿HANDLING EMERGENCIES¿ LISTS EXAMPLES OF EMERGENCIES, INCLUDING COMMUNICATION FAULT ALARMS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A COMMUNICATION FAULT ALARM. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED DRIVELINE COMMUNICATION A FAULTS ON 19JUL2024. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED WHICH RESOLVED THE FAULT. THE MODULAR CABLE HAD RESCUE TAPE FOR SOME DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2294491 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7221683 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male