BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 18947011 · Received March 20, 2024

    Report

    Report Number
    2916596-2024-01724
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    March 14, 2024
    Report Date
    August 22, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D1: BRAND NAME CORRECTED SECTION D4: CATALOG NUMBER AND PRIMARY UDI CORRECTED SECTION H6: MEDICAL DEVICE PROBLEM CODE CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENTS OF DRIVELINE POWER FAULT ALARMS, DRIVELINE COMMUNICATION FAULT ALARMS, AND KINKS IN THE MODULAR CABLE WERE CONFIRMED; HOWEVER, THE REPORTED EVENT OF THE INLINE CONNECTOR NUT BEING DIFFICULT TO FASTEN AND REMAINING FASTENED WAS UNABLE TO BE CONFIRMED. THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: 8894603) WAS RETURNED FOR EVALUATION AND A LOG FILE (20240314_104327) WAS SUBMITTED AND DOWNLOADED (E3201000) FROM THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: HSC-123624) FOR REVIEW THAT SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 7 HOURS (14MAR2024 FROM 16:58:19 - 23:11:07, 01JAN2000 PER TIMESTAMP). DRIVELINE POWER FAULT ALARMS WERE ACTIVE DUE TO A POWER B BROKEN FAULT ON 14MAR2024 FROM 19:31:24. THE ALARM CLEARED UPON THE DISCONNECTION OF THE DRIVELINE AT 19:31:48. DRIVELINE POWER FAULT ALARMS THAT WERE ASSOCIATED WITH A POWER B BROKEN FAULT AND DRIVELINE COMMUNICATION FAULT ALARMS THAT WERE ASSOCIATED WITH A COM B FAULT ACTIVE ON 14MAR2024 FROM 19:32:39 ¿ 23:00:41. THE ALARMS RESOLVED WHEN THE DRIVELINE WAS DISCONNECTED SHORTLY AFTER AT 23:10:01 FOR A SYSTEM CONTROLLER EXCHANGE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. AN IMAGE WAS SUBMITTED FOR REVIEW THAT SHOWED KINKS IN THE MODULAR CABLE, AND THE INLINE CONNECTOR NUT WAS NOT FULLY FASTENED TO THE PUMP CABLE. THE RETURNED MODULAR CABLE WAS TESTED INDIVIDUALLY WITH THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBERS: HSC-123624) AS WELL AS A TEST SYSTEM CONTROLLER. THE CONTROLLERS WERE RUN ON THE MOCK LOOP WITH THE RETURNED MODULAR CABLE FOR AN EXTENDED DURATION. DURING TESTING THE MODULAR CABLE WAS MANIPULATED BY HAND. THE INLINE CONNECTOR NUT WAS ABLE TO BE FULLY FASTENED TO THE PUMP CABLE WITHOUT ANY ISSUES OR EXTRA FORCE BEING REQUIRED AND REMAINED FULLY FASTENED THROUGHOUT TESTING. THE MODULAR CABLE PASSED ALL TESTING WITHOUT ANY ISSUES OR ALARMS BECOMING ACTIVE DURING TESTING. THE OUTER JACKET OF THE CABLE WAS STRIPPED AND NOTABLE KINKS IN THE UNDERLYING WIRES WERE OBSERVED. ADDITIONAL INFORMATION PROVIDED ON 19MAR2024 STATED THE CAUSE OF THE ALARMS WAS NOT IDENTIFIED, AND THAT THE ALARMS RESOLVED FOLLOWING THE MODULAR CABLE AND SYSTEM CONTROLLER EXCHANGE. 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: 8894603) 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 AND DRIVELINE POWER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EVENT LOG FILES WERE SUBMITTED FOR REVIEW FOR DUE TO CONCERN FOR MODULAR CABLE DAMAGE. THE PATIENT REPORTED A DRIVELINE POWER FAULT AND ARRIVED AT THE HOSPITAL FOR EVALUATION WITH LOW POWER ADVISORIES, DRIVELINE POWER FAULTS, AND DRIVELINE COMMUNICATION FAULTS. THE CAUSE OF THE ALARMS WAS BELIEVED TO BE THE MODULAR CABLE. THE PATIENT HAD 14 PUMP STOPS OVER THE SPAN OF 30 MINUTES. THE PATIENT WAS UNAWARE THAT THE PUMP STOPPED. THE MODULAR CABLE WAS VISIBLY KINKED FROM THE SYSTEM CONTROLLER TO THE MODULAR CABLE CONNECTION. THE PATIENT NOTED THAT THE MODULAR CABLE CONNECTION LOCK WOULD NOT STAY LOCKED. THE MODULAR CABLE AND SYSTEM CONTROLLER WAS EXCHANGED AS A POWER ALARM INTERMITTENTLY OCCURRED. THE EVENT LOG FILES CAPTURED PUMP OFF EVENTS ON (B)(6) 2024 FROM 19:19 TO 19:33 FOLLOWED BY DRIVELINE POWER FAULTS AND DRIVELINE COMMUNICATION FAULTS. THE ALARMS RESOLVED AFTER THE EXCHANGE. THE PATIENT WAS DISCHARGED. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01725 (SYSTEM CONTROLLER (B)(6)). RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01727 (PUMP (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748600 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8894603 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention