BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 18086680 · Received November 7, 2023

    Report

    Report Number
    2916596-2023-07583
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 18, 2023
    Report Date
    May 24, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1: CORRECTED. SECTION D4, LOT NUMBER: CORRECTED. SECTION D4, PRIMARY UDI NUMBER: CORRECTED. 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 A YELLOW WRENCH CONTROLLER FAULT ALARM WAS CONFIRMED DURING REVIEW OF THE SUBMITTED AND DOWNLOADED LOG FILES. THE LOG FILES COLLECTIVELY CONTAINED DATA SPANNING APPROXIMATELY 5 DAYS OF PATIENT USE ( (B)(6) 2023 PER TIMESTAMP). A CONTROLLER FAULT ALARM WAS OBSERVED AT 3:43:44 ON 18OCT2023 DUE TO A BOOST OVER VOLTAGE FAULT. THE VOLTAGES OF THE POWER CABLES AND MOTOR APPEARED TO BE WITHIN NORMAL RANGES AT THE TIME OF THE FAULT'S ACTIVATION. THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP WAS UNAFFECTED BY THE FAULT/ALARM, AS THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT WHILE THE DRIVELINE WAS CONNECTED. THE DRIVELINE WAS DISCONNECTED AT 4:32:06 ON 18OCT2023, WHICH IS CONSISTENT WITH THE CONTROLLER¿S EXCHANGE. THE CONTROLLER FAULT ALARM AND BOOST OVER VOLTAGE FAULT REMAINED ACTIVE UNTIL THE CONTROLLER WAS POWERED DOWN FOLLOWING THE CONTROLLER EXCHANGE. THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: HSC-083793) WAS FUNCTIONALLY TESTED AND FOUND TO PERFORM AS INTENDED; THE REPORTED EVENT COULD NOT BE REPRODUCED. THE CONTROLLER PASSED ALL STEPS OF TESTING AND WAS ABLE TO OPERATE A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD OF TIME WITHOUT ISSUE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) ) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (REV D - SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) COVERS ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THOSE ASSOCIATED WITH CONTROLLER INTERNAL FAULT CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARM CANNOT BE RESOLVED. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D - SECTION 6 ¿CARING FOR THE EQUIPMENT¿) DESCRIBES HOW TO PROPERLY CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER AND ITS POWER CABLES. THE PATIENT HANDBOOK CAUTIONS 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. 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED A YELLOW WRENCH CONTROLLER FAULT ALARM ON (B)(6) 2023 AND PERFORMED A CONTROLLER EXCHANGE AT HOME. THE LOG CAPTURED CONTROLLER INTERNAL FAULT (F24 BOOST OV) ON (B)(6) 2023 FROM 03:43-04:32. THE DRIVELINE WAS DISCONNECTED FOR THE CONTROLLER EXCHANGE AT (B)(6) 2023 AT 04:32. THE ALARMS INDICATED THAT THE BOOST OVER VOLTAGE HAS BEEN ACTIVATED (RARE). A CONTROLLER REPLACEMENT WAS CONSIDERED WARRANTED TO FIX THESE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338690 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7273677 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male