BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 24798104 · Received April 7, 2026

    Report

    Report Number
    2916596-2026-01758
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 20, 2026
    Report Date
    May 11, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED HEARTMATE 3 MODULAR CABLE CONFIRMED WIRE DAMAGE THAT WOULD HAVE CAUSED THE REPORTED DRIVELINE COMMUNICATION FAULT AND DRIVELINE POWER FAULT ALARMS OBSERVED IN THE SUBMITTED LOG FILES. THE HEARTMATE 3 MODULAR CABLE, LOT NUMBER 8062784, WAS RETURNED IN USED CONDITION. EXAMINATION OF THE OUTER JACKET REVEALED A GRAY DISCOLORATION ALONG THE LENGTH OF THE CABLE. THE OUTER JACKET SHOWED NO OTHER SIGNS OF DAMAGE (CUTS, HOLES, TEARS, ETC.). THE INLINE AND CONTROLLER CONNECTOR BEND RELIEFS WERE DISCOLORED DARK BROWN BUT WERE OTHERWISE UNREMARKABLE. REVIEW OF THE SUBMITTED LOG FILES CAPTURED SUSTAINED DRIVELINE POWER FAULT AND COMMUNICATION FAULT ALARMS ON 20MAR2026. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE STORED PATIENT SPEED. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED THROUGHOUT THE LOG FILES. THE MODULAR CABLE WAS CONNECTED TO A TEST PUMP CABLE AND OPERATED ON A MOCK CIRCULATORY LOOP USING A TEST PUMP. THE REPORTED DRIVELINE ALARMS WERE REPRODUCED. THE MODULAR CABLE WAS THEN TESTED TO EVALUATE THE INTEGRITY OF ITS WIRES. THE MODULAR CABLE DID NOT PASS ELECTRICAL TESTING, EVEN AFTER CLEANING OF THE PINS. ELECTRICAL CONTINUITY TESTING OF THE MODULAR CABLE WAS PERFORMED WITH A TEST BULKHEAD AND TEST DISTAL PUMP CABLE SEGMENT. RESISTANCE VALUES OF THE GREEN AND BLACK WIRES MEASURED "OL", INDICATING THAT THERE WAS NO CONTINUITY IN THESE WIRES. THE OPEN LOOP MEASURED IN THE BLACK WIRE ASSOCIATED WITH POWER AND GREEN WIRE ASSOCIATED WITH COMMUNICATION APPEARS CONSISTENT WITH THE REPORTED DRIVELINE FAULT ALARMS. NO OTHER DISCONTINUITIES OR SHORTS WERE INDUCED IN THE OTHER WIRES DURING THIS TESTING. AFTER FUNCTIONAL TESTING, THE UNDERLYING LAYERS OF THE CABLE WERE INSPECTED. THE UNDERLYING ARMOR AND BIONATE LAYERS APPEARED UNREMARKABLE. UPON REMOVAL OF THE BIONATE LAYER, THE WIRES WERE CAREFULLY INSPECTED AND REVEALED THE BLACK AND GREEN WIRES WERE COMPLETELY FRACTURED APPROXIMATELY 10.0" FROM THE CONTROLLER CONNECTOR. VISUAL AND MICROSCOPIC INSPECTION OF THE REMAINING WIRE SECTIONS REVEALED NO OBVIOUS SIGNS OF DAMAGE TO THE WIRE INSULATIONS OR THE UNDERLYING CONDUCTORS. THE AVAILABLE INFORMATION INDICATED THAT THE PATIENT'S MODULAR CABLE WAS EXCHANGED, AND IT RESOLVED ALL ALARMS. ATTEMPTS WERE MADE TO REQUEST FOR THE CONTROLLER EVENT LOG FILE. HOWEVER, THE ACCOUNT INDICATED THROUGH GOOD FAITH EFFORTS THAT NO CONTROLLER EVENT LOG FILE WAS AVAILABLE FOR REVIEW. THE ROOT CAUSE FOR THE REPORTED ALARMS WAS DETERMINED TO BE WIRE FATIGUE; ALTHOUGH, A SPECIFIC CAUSE FOR THE FATIGUE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTIONS 2 AND 6 OF THE IFU AND SECTIONS 2 AND 4 OF THE PATIENT HANDBOOK CAUTION THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE AND FURTHER EMPHASIZE NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, WHICH MAY CAUSE DAMAGE TO THE WIRES. SECTION 6 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK ALSO INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO INSTRUCTS THE USED TO CALL THE HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED). SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, ADDRESS SYSTEM ALARMS, INCLUDING DRIVELINE COMMUNICATION FAULTS, AS WELL AS THE RECOMMENDED ACTIONS ASSOCIATED WITH EACH. THESE SECTIONS ALSO PROVIDE INSTRUCTIONS REGARDING HOW TO CARE FOR THE DRIVELINE IN SUB-SECTIONS ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." SECTION 8 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK CONTAIN ADDITIONAL INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THESE SECTIONS INSTRUCT THE USER TO KEEP THE DRIVELINE CLEAN AND WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, 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. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE COMMUNICATION FAULTS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THESE EMERGENCIES. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER 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. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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. THE PATIENT'S MODULAR CABLE WAS EXCHANGED, AND IT RESOLVED ALL ALARMS. ON THE PATIENT'S SIDE OF THE DRIVELINE CONNECTION, THERE WAS A KINK WITH EXPOSED CASING THAT WAS RESCUE TAPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537007 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8062784 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1