BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 19462988 · Received June 4, 2024

    Report

    Report Number
    2916596-2024-02984
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    April 2, 2024
    Report Date
    August 21, 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
    OTHER HEALTH CARE PROFESSIONAL
    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; HOWEVER, THE REPORTED EVENT OF CORROSION WITHIN THE INLINE CONNECTOR OF THE MODULAR CABLE WAS UNABLE TO BE CONFIRMED. THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 7717204) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, LOG FILES WERE SUBMITTED FOR REVIEW FROM THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) THAT SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 1 HOUR. THE DRIVELINE WAS CONNECTED TO THE SYSTEM CONTROLLER ON (B)(6) 2024 AT 09:40:44. DRIVELINE COMMUNICATION FAULT ALARMS THAT WERE ASSOCIATED WITH A COMM A AND COM B FAULT WERE ACTIVE ON (B)(6) 2024 FROM 09:41:12 ¿ 10:37:54. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. ADDITIONAL INFORMATION PROVIDED ON 12APR2024 STATED THE PATIENT DOES NOT RECALL EXPOSING THE DRIVELINE TO ANY FLUIDS, AND THAT THE COMM B FAULTS RESOLVED FOLLOWING THE DRIVELINE CONNECTOR CLEANING. A ROOT CAUSE FOR REPORTED EVENTS WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 7717204) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK 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 SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 2 ¿SYSTEM OPERATIONS¿ EXPLAIN HOW TO REPLACE THE RUNNING SYSTEM CONTROLLER WITH THE BACKUP SYSTEM CONTROLLER. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) 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 LVAS PATIENT HANDBOOK 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 THE PATIENT HAD A DRIVELINE FAULT ALARM STARTING ON (B)(6)2024 AROUND 11PM. THE PATIENT WAS DOING WELL WITH NO CHANGES TO FLOWS. THE PATIENT DID NOT RECALL EXPOSING THE DRIVELINE OR MODULAR CABLE CONNECTION TO ANY FLUIDS. LOG FILES WERE SUBMITTED FOR REVIEW AND RECORDED A DRIVELINE FAULT AT (B)(6)2024 22:38:24. THE EVENT LOG ASSOCIATED THIS EVENT WITH AN F20 COMMUNICATION B FAULT. MOTOR FUNCTION WAS NOT AFFECTED BY THIS EVENT. IT WAS SUGGESTED TO REPLACE THE MODULAR CABLE WITH SYSTEM CONTROLLER AND CONTINUE TO MONITOR FOR UNUSUAL EVENTS. ADDITIONALLY, IT WAS SUGGESTED TO TEMPORARILY SET THE RECORDING FREQUENCY OF THE PERIODIC LOG TO 10-MINUTE INTERVALS, SO DATA WAS CAPTURED MORE FREQUENTLY. FOLLOW UP LOG FILES FOR THE NEW SYSTEM CONTROLLER AND MODULAR CABLE WERE SUBMITTED FOR EVALUATION AND RECORDED A DRIVELINE FAULT ASSOCIATED WITH AN F20 COMMUNICATION B FAULT WHICH DID NOT AFFECT PUMP FUNCTIONALITY. IMAGES APPEARED TO SHOW SIGNED OF CORROSION OF THE MODULAR CABLE. A DRIVELINE CONNECTOR CLEANING WAS PERFORMED ON 04APR2024 TO RESOLVE THE ALARMS. SURFACE CORROSION ON THE SURFACE OF THE PUMP END CONNECTOR WAS NOTED. THE SURFACE CORROSION AND FEMALE PIN WAS CLEANED OFF WITH 99% ALCOHOL AND A TOOTHBRUSH WITH NO ISSUES. THERE WERE NO FURTHER COMMUNICATION FAULTS NOTED POST CLEANING. THIS WAS VERIFIED ON THE HEARTMATE TOUCH AND ALSO WITH A LOG FILE. THE PATIENT TOLERATED THE PUMP OFF PERIODS WELL AND WAS EDUCATED TO COVER THE CONNECTION WHEN SHOWERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666898 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7717204 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male