BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 22123917 · Received June 2, 2025

    Report

    Report Number
    2916596-2025-03647
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    October 4, 2024
    Report Date
    July 22, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE ON THE MODULAR CABLE (LOT NUMBER: 7171211) WAS UNABLE TO BE CONFIRMED. THE MODULAR CABLE WAS NOT RETURNED FOR ANALYSIS AND NO PHOTOS OF THE DAMAGE WERE SUBMITTED. THE SUBMITTED LOG FILES SHOWED NO INDICATION THAT THE DAMAGE PREVENTED THE CONTROLLER FROM SUPPORTING THE SYSTEM AS INTENDED. PROVIDED INFORMATION INDICATED THAT THE MODULAR CABLE WAS EXCHANGED, AND THAT THE PATIENT EXPERIENCED NO ADVERSE EFFECTS FROM THE EXCHANGE. THE ROOT CAUSE FOR THE DAMAGE WAS NOT ABLE TO BE CONCLUSIVELY DETERMINED VIA THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND REVEALED NO DEVIATIONS FROM MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE III INSTRUCTIONS FOR USE (REV. C) SECTION 2 - ¿SYSTEM OPERATIONS¿ AND HEARTMATE III PATIENT HANDBOOK (REV. D) SECTION 2 - ¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. 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 THE PATIENT UNDERWENT A SYSTEM CONTROLLER, EMERGENCY BACKUP BATTERY, AND MODULAR CABLE EXCHANGE DUE TO EXPOSED MODULAR CABLE WIRES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR THE SYSTEM CONTROLLER EXCHANGE WAS DUE TO NEW EQUIPMENT GIVEN TO PATIENT AFTER THEIR DRIVELINE REPAIR. THE EMERGENCY BACKUP BATTERY WAS EXCHANGED DUE TO THE SYSTEM CONTROLLER EXCHANGE. IT WAS REPORTED THE EXCHANGES RESOLVED THE EVENT. LOG FILES WERE SUBMITTED FOR REVIEW. THE EVENT LOG FILE CONTAINED CLUSTERS OF PULSATILITY INDEX EVENTS AS WELL AS ROUTINE POWER SOURCE CHANGES. NO ABNORMAL SYSTEM CONTROLLER ALARMS OR PUMP FAULTS WERE SEEN IN THE LOG. THE PUMP APPEARED TO HAVE BEEN OPERATING AS INTENDED. IT WAS ALSO SAID THAT THE PATIENT SUFFERED NO ADVERSE HEALTH EVENTS DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602755 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7171211 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male