BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 22198922 · Received June 12, 2025

    Report

    Report Number
    2916596-2025-03598
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    April 20, 2025
    Report Date
    July 24, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011729
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ALARMS WAS CONFIRMED VIA LOG FILE REVIEW. ON (B)(6) 2025, AT 19:08:30 A DRIVELINE POWER FAULT ALARM ACTIVATES ASSOCIATED WITH A POWER B BROKEN FAULT. SIMILARLY, ON (B)(6) 2025, DRIVELINE POWER FAULT ALARMS ARE ACTIVE FROM 9:45:21 - 12:35:28, THE ALARM WAS ASSOCIATED WITH POWER B BROKEN FAULTS. THE DRIVELINE WAS DISCONNECTED AT 12:35:28 CONSISTENT WITH THE REPORTED CONTROLLER EXCHANGE. THE MODULAR CABLE (LOT: 8922880) WAS NOT RETURNED FOR TESTING. PROVIDED INFORMATION REVEALED THAT THE SYSTEM CONTROLLER AND MODULAR CABLE (LOT: 8922880) WERE INITIALLY EXCHANGED AND THE ALARMS RETURNED. THE MODULAR CABLE (LOT: 10706578) TO PUMP CABLE CONNECTION OF THE DRIVELINE WAS DISCONNECTED AND THE PINS AND PLUGS WERE CLEANED; THIS RESOLVED THE ALARMS. PROVIDED INFORMATION REVEALED THAT CLEANING THE MOD CABLE-DRIVELINE CONNECTION RESOLVED THE ALARMS, HOWEVER A ROOT CAUSE OF THE REPORTED DRIVELINE POWER FAULT ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, OUTLINE ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE POWER 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 CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS WAS CONFIRMED VIA LOG FILE REVIEW. ON 20APR2025, AT 19:08:30 A DRIVELINE POWER FAULT ALARM ACTIVATES ASSOCIATED WITH A POWER B BROKEN FAULT. SIMILARLY, ON 09MAY2025, DRIVELINE POWER FAULT ALARMS ARE ACTIVE FROM 9:45:21 - 12:35:28, THE ALARM WAS ASSOCIATED WITH POWER B BROKEN FAULTS. THE DRIVELINE WAS DISCONNECTED AT 12:35:28 CONSISTENT WITH THE REPORTED CONTROLLER EXCHANGE. INSPECTION OF THE RETURNED MODULAR CABLE (LOT NUMBER: 8922880) REVEALED CORROSION AROUND ALL OF THE PINS IN THE INLINE CONNECTOR. INTERNAL RESISTANCES WERE MEASURED AND SLIGHTLY ELEVATED RESISTANCES WERE OBSERVED. THE OBSERVED CORROSION ON THE ELECTRICAL CONTACTS CAN CONTRIBUTE TO HIGHER RESISTANCE. THE RETURNED MODULAR CABLE WAS THEN CONNECTED TO A TEST SYSTEM CONTROLLER AND A TEST PUMP WITH NO ISSUES OBSERVED. THE MODULAR CABLE OPERATED THE TEST PUMP WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED, INCLUDING WHEN THE MODULAR CABLE WAS MANIPULATED BY HAND. ALTHOUGH THE REPORTED DRIVELINE POWER FAULT ALARMS WERE NOT REPRODUCED DURING TESTING, THE OBSERVED CORROSION ON THE PINS IN THE INLINE CONNECTOR COULD HAVE RESULTED IN THE REPORTED ALARMS. PROVIDED INFORMATION REVEALED THAT THE SYSTEM CONTROLLER AND MODULAR CABLE (LOT: 8922880) WERE INITIALLY EXCHANGED AND THE ALARMS RETURNED. THE MODULAR CABLE (LOT: 10706578) TO PUMP CABLE CONNECTION OF THE DRIVELINE WAS DISCONNECTED AND THE PINS AND PLUGS WERE CLEANED, THIS RESOLVED THE ALARMS. PROVIDED INFORMATION REVEALED THAT CLEANING THE MOD CABLE-DRIVELINE CONNECTION RESOLVED THE ALARMS, HOWEVER A ROOT CAUSE OF THE REPORTED DRIVELINE POWER FAULT ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. ALTHOUGH NOT CONFIRMED, THE OBSERVED CORROSION ON THE PINS IN THE INLINE CONNECTOR MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU, AND THE HEARTMATE 3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, OUTLINE ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, LISTS EXAMPLES OF EMERGENCIES, INCLUDING DRIVELINE POWER 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 CURRENT REVISION OF THE IFU CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DRIVELINE POWER FAULT OCCURRED, AND A MODULAR CABLE EXCHANGE WAS PLANNED FOR (B)(6) 2025. THERE WERE NO FURTHER ALARMS AFTER THE MODULAR CABLE EXCHANGE. IT WAS ADDITIONALLY REPORTED THE DRIVELINE POWER FAULT REOCCURRED AND THE SYSTEM CONTROLLER WAS EXCHANGED. IT WAS ADDITIONALLY REPORTED ON (B)(6) 2025 THAT THE PATIENT HAD A REOCCURRENCE OF DRIVELINE POWER FAULT. THE PATIENT WAS ADMITTED, AND THE REPORTED FAILURE WAS CONFIRMED THROUGH LOG FILES. THE MODULAR CABLE TO PUMP CABLE CONNECTION OF THE DRIVELINE WAS DISCONNECTED AND THE PINS AND PLUGS WERE CLEANED. THE PUMP WAS RESTARTED WITHOUT ANY ISSUES AND THE ALARM HAD DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635400 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 8922880 00813024011729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown