BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 22639934 · Received July 28, 2025

    Report

    Report Number
    2916596-2025-04954
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 23, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE MODULAR CABLE, LOT NUMBER: 7964945, WAS NOT RETURNED; HOWEVER, LOG FILES WERE AVAILABLE FOR ITS EVALUATION. ALL ITEMS NOT ASSOCIATED WITH THE MODULAR CABLE ARE ADDRESSED WITHIN THE SYSTEM CONTROLLER INVESTIGATION. THE ASSOCIATED SYSTEM CONTROLLER EVENT LOG FILE WAS REVIEWED, AND TIMESTAMPS SPANNED APPROXIMATELY 1 HOUR (12:58:50 TO 13:57:04 ON (B)(6) 2025). THERE WERE NO EVENTS FOUND WITHIN THIS LOG FILE THAT PERTAIN TO ISSUES WITH THE MODULAR CABLE. THE PUMP MAINTAINED A SPEED WITHIN THE EXPECTED RANGE THROUGHOUT THE LOG FILE. THERE WERE NO ISSUES FOUND WITH THE MODULAR CABLE. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE HEARTMATE VAD MODULAR CABLE, LOT NUMBER: 7964945, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. AN ARE CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU (REV. D) SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND THE HEARTMATE 3 PATIENT HANDBOOK (REV. A) SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESS HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. THE HEARTMATE 3 PATIENT HANDBOOK (REV. A) 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CALLED THE HEALTHCARE PROVIDER ON (B)(6) 2025 BECAUSE THEIR SYSTEM CONTROLLER WAS ALARMING. THE PATIENT HAD CONNECTED TO THE MOBILE POWER UNIT (MPU) AND STARTED HAVING A "CONNECT TO POWER" ALARM ON THEIR SYSTEM CONTROLLER WITH THE YELLOW WRENCH. WHEN CONNECTED TO THE BATTERY(S), THE ALARM CONTINUED AND WAS ALSO READING "CALL HOSPITAL/BACKUP BATTERY FAULT". A SELF TEST WAS PERFORMED AND THE ALARM CLEARED. WHEN THE PATIENT RETURNED TO THE MPU, THE ALARMS BEGAN AGAIN. THE PATIENT WENT BACK ON BATTERY POWER AND THE ALARMS CONTINUED. PER THE PATIENT, THE ALARM SAID "LOW BATTERY", AND WHEN ASKED, WAS UNABLE TO IDENTIFY IF THERE WAS A YELLOW LIGHT AT THE WHITE OR BLACK POWER CABLE CONNECTION SITES. NEW BATTERY(S) WERE PLACED AND THIS STOPPED THE ALARM. ON (B)(6) 2025, THE PATIENT WAS AT THE HOSPITAL WITH A COMPLAINT OF BACKUP BATTERY FAULT, LOW BATTERY, AND POWER CABLE DISCONNECT ALARMS WHILE ON THE WHITE SYSTEM CONTROLLER LEAD. FOLLOWING REVIEW, LOG FILES CONTAINED MULTIPLE LOW VOLTAGE ADVISORY(S) WHILE THE PATIENT WAS UTILIZING BATTERY POWER, AND APPEARED MORE FREQUENTLY ON THE WHITE POWER CABLE SIDE. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED, NO ALARMS SINCE, INCLUDING WHILE USING THE EXISTING BATTERY CLIP(S) AND THE MOBILE POWER UNIT (MPU), WHICH ALSO WERE FREE FROM VISUAL PHYSICAL DAMAGE. THE SYSTEM CONTROLLER AND MODULAR CABLE WOULD BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    THERE WERE NO EVENTS FOUND WITHIN THE LOG FILES THAT INDICATED AN ISSUE WITH THE MODULAR CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476018 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7964945 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female