BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 23259922 · Received October 9, 2025

    Report

    Report Number
    2916596-2025-06546
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 10, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT AND DRIVELINE COMMUNICATION FAULT ALARMS WERE CONFIRMED VIA THE SUBMITTED LOG FILES AND DURING EVALUATION OF THE RETURNED MODULAR CABLE. THE REPORTED CORROSION WAS CONFIRMED VIA EVALUATION OF THE RETURNED MODULAR CABLE. THE SUBMITTED LOG FILES FROM CONTROLLER, SERIAL NUMBER (B)(6), CAPTURED DRIVELINE POWER FAULT ALARMS DUE TO INTERMITTENT POWER B BROKEN FAULTS ON (B)(6) 2025 AT 14:46:01. THE ALARMS WERE ACTIVE UNDER THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2025 AT 19:47:47. ON (B)(6) 2025 AT 19:48:07, THE LOG FILE CAPTURED A DRIVELINE COMMUNICATION FAULT ALARM DUE TO INTERMITTENT COMMUNICATION A FAULTS AND COMMUNICATION B FAULTS. THE ALARM BRIEFLY RESOLVED BRIEFLY WHEN THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2025 FROM 20:18:52-20:19:16 BUT REACTIVATED SHORTLY AFTER THE DRIVELINE WAS RECONNECTED. THIS IS CONSISTENT WITH REPORTED MODULAR CABLE EXCHANGE. THE SUBMITTED LOG FILES FROM CONTROLLER, SERIAL NUMBER HSC-(B)(6), WERE REVIEWED AND DID NOT CAPTURE ANY ADDITIONAL DRIVELINE POWER OR COMMUNICATION FAULT ALARMS. THE RETURNED MODULAR CABLE, LOT NUMBER 9072157, WAS VISUALLY INSPECTED AND CORROSION CONSISTENT WITH FLUID INGRESS WAS REVEALED ON ALL PINS IN THE INLINE CONNECTOR. THE MODULAR CABLE WAS CONNECTED TO A TEST SYSTEM CONTROLLER AND MOCK CIRCULATORY LOOP AND A DRIVELINE COMMUNICATION FAULT ALARM ACTIVATED. LOG FILES WERE DOWNLOADED FROM THE TEST CONTROLLER, AND THE ALARMS WERE REVEALED TO BE DUE TO COMMUNICATION B FAULTS. THE INTEGRITY OF THE UNDERLYING WIRES WAS TESTED AND DID NOT PASS DUE TO THE OBSERVED CORROSION. THE PROVIDED INFORMATION INDICATED THE MODULAR CABLE WAS EXCHANGED ON (B)(6) 2025. THE CONTROLLER AND SECOND MODULAR CABLE WERE EXCHANGED AFTER THE PUMP CABLE WAS CLEANED ON (B)(6) 2025. THE ALARMS RESOLVED AFTER THE PUMP CABLE CLEANING. THE ROOT CAUSE FOR THE DRIVELINE COMMUNICATION FAULT ALARMS WAS DETERMINED TO BE DUE TO FLUID INGRESS ON THE PINS IN THE INLINE CONNECTOR. ALTHOUGH NOT REPRODUCED, THE DRIVELINE POWER FAULT ALARMS ARE CONSISTENT WITH THE OBSERVED FLUID INGRESS. A ROOT CAUSE FOR THE OBSERVED FLUID INGRESS WAS NOT DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEAL THAT THE HEARTMATE MODULAR CABLE, LOT NUMBER 9072157, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU AND HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 7 OF THE IFU, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INSTRUCTION ON HOW TO IDENTIFY AND TROUBLESHOOT DRIVELINE POWER FAULT AND DRIVELINE COMMUNICATION FAULT ALARMS. SECTION 2 OF THE IFU, ENTITLED ¿SYSTEM OPERATIONS¿, INSTRUCTS THE USER TO NOT EXPOSE THE EXTERNAL SYSTEM COMPONENTS TO WATER OR MOISTURE. SECTION F OF THE IFU, ENTITLED ¿SAFETY CHECKLISTS¿ INSTRUCTS USERS TO INSPECT THE DRIVELINE FOR DAMAGE DAILY. THE PATIENT HANDBOOK WHICH WAS AVAILABLE FOR USE AT THE TIME OF THE EVENT, 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 LOG FILES WERE SENT FOR REVIEW. THE EVENT LOG FILE RECORDED A DRIVELINE POWER FAULT ALARM FLAG ON (B)(6) 2025 AT 14:46:01. THE EVENT LOG FILE DATA INDICATED THAT THIS ALARM CONTINUED UNTIL A DRIVELINE DISCONNECT WAS RECORDED ON (B)(6) 2025 AT 19:47:47. THE DATA INDICATED THAT THE DRIVELINE CONNECTION WAS REESTABLISHED ON (B)(6) 2025 AT 19:47:54. DRIVELINE COMMUNICATION FAULT ALARM FLAGS WERE THEN RECORDED ON (B)(6) 2025 AT 19:48:07. THE DRIVELINE WAS DISCONNECTED WHEN THE MODULAR CABLE WAS EXCHANGED AT 8:10 PM ON (B)(6) 2025 IN AN ATTEMPT TO RESOLVE THE DRIVELINE POWER FAULT. EXCHANGING THE MODULAR CABLE CLEARED THE ALARM FOR ONE HOUR, BUT THE SYSTEM CONTROLLER THEN ALARMED WITH A DRIVELINE COMMUNICATION FAULT. THIS KIND OF BEHAVIOR HAD BEEN LINKED TO CORROSION IN THE DRIVELINE/MODULAR CABLE CONNECTOR. ADDITIONAL LOG FILES WERE SENT FOR REVIEW WITH DRIVELINE COMMUNICATION FAULT ALARM NOTED ON (B)(6) 2025 AT 21:33. THE EVENT LOG CAPTURED DRIVELINE COMM FAULTS (COMM A) IN THIS RECENT LOG FILE DATA. IT WAS NOTED THAT THE COMM FAULTS WERE SWITCHING BACK AND FORTH BETWEEN COMM A AND COMM B WHICH WAS INDICATIVE OF A DEBRIS/CORROSION ISSUE IN THE CONNECTOR. THE OUTER CASING OF THE FAULTY MODULAR CABLE SEEMED TO BE INTACT WITHOUT ANY SIGNS OF DAMAGE. THE CONNECTION APPEARED TO HAVE SOME CORROSION ON IT WHICH COULD BE OXIDATION SECONDARY TO LIQUID EXPOSURE. THERE WERE SIGNS OF CORROSION ON THE MODULAR CABLE SIDE OF THE CONNECTION. BASED ON THE LOG FILE DATA, IT WAS EXPECTED THAT THERE WAS ALSO SOME CORROSION ON THE DRIVELINE SIDE AS WELL. A CLEANING OF THE PUMP SIDE CABLE CONNECTOR WAS PERFORMED ON (B)(6) 2025. LOG FILES WERE SENT FOR REVIEW STATUS POST MODULAR CABLE CLEANING. THE LOG FILE CAPTURED ROUTINE EVENTS. THERE WERE NO NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES. THE DRIVELINE POWER AND COMMUNICATION FAULTS HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173663 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 9072157

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male