BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 20611787 · Received November 5, 2024

    Report

    Report Number
    2916596-2024-06906
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 10, 2024
    Report Date
    December 9, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE COMMUNICATION FAULT ALARMS WAS CONFIRMED VIA LOG FILE ANALYSIS. THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 7990776) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED (B)(4) FOR REVIEW THAT SHOWED EVENTS SPANNING APPROXIMATELY 4 HOURS (B)(6) 2024 FROM 08:26:57 - 12:44:17 PER TIMESTAMP). DRIVELINE COMMUNICATION FAULT ALARMS ASSOCIATED WITH A COM B FAULT WERE ACTIVE THROUGHOUT THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED BY THESE ALARMS. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. MULTIPLE GOOD FAITH EFFORTS WERE SENT ASKING IF ANY PRODUCT WOULD BE RETURNED FOR ANALYSIS, AND IF THERE WERE ANY ADVERSE CONSEQUENCES DUE TO THE PATIENT PULLING THE DRIVELINE. TO DATE, NO RESPONSE HAS BEEN PROVIDED. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 7990776) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK, REV. D SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ INSTRUCTS USERS ON HOW TO RESOLVE ALARMS THAT SOUND FROM THEIR SYSTEM CONTROLLER, INCLUDING DRIVELINE COMMUNICATION FAULT ALARMS. HEARTMATE 3 PATIENT HANDBOOK, REV. D SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU), REV. C SECTION 2 ¿SYSTEM OPERATIONS¿ EXPLAIN HOW TO REPLACE THE RUNNING SYSTEM CONTROLLER WITH THE BACKUP SYSTEM CONTROLLER. HEARTMATE 3 IFU, REV. C SECTION 5 "SURGICAL PROCEDURES" CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 "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 LEFT VENTRICULAR ASSIST DEVICE TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN." SECTION 6 (UNDER "CARING FOR THE DRIVELINE") INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 7 "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" (UNDER "CLEANING THE DRIVELINE") STATES, "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK, REV. D SECTION 4 "LIVING WITH THE HEARTMATE 3" (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER: "CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." AND "KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID." IN ADDITION, SECTION 5 "ALARMS AND TROUBLESHOOTING" CONTAINS A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES", WHICH EXPLICITLY CAUTIONS THE USER NOT TO TWIST. 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 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 COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT APPEARED TO CLINIC WITH A DRIVELINE (DL) COMMUNICATION FAULT ALARM. THE CLINICIAN ATTEMPTED TO CLEAR THE ALARM FROM THE SCREEN, BUT THE ALARM REOCCURRED SECONDS AFTER CLEARING IT MULTIPLE TIMES. THE PATIENT HAD A HISTORY OF PULLING AT THE DL AFTER HEAD TRAUMA THAT OCCURRED EARLIER THIS YEAR, WHICH WAS BELIEVED TO BE THE CAUSE OF THIS DAMAGE. THE PATIENT HAD NOT PULLED ON THE LINE RECENTLY. LOG FILES WERE SUBMITTED FOR REVIEW. THE EVENT LOG CAPTURED DL COMMUNICATION FAULTS THROUGHOUT THE LOG AFFECTING LINE B IN THE DL. THE MODULAR CABLE AND THE SYSTEM CONTROLLER WERE EXCHANGED WHICH RESOLVED THE FAULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46534 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7990776 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male