BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE II®, SYSTEM CONTROLLER

    MDR report key: 24120958 · Received January 20, 2026

    Report

    Report Number
    2916596-2026-00450
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 30, 2025
    Report Date
    March 31, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    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. MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A CONTROLLER FAULT ALARM BEING DISPLAYED ON THE HEARTMATE II SYSTEM CONTROLLER WAS NOT CONFIRMED VIA THE SUBMITTED LOG FILE. THE PROVIDED INFORMATION INDICATED THE PATIENT OBSERVED A CONTROLLER FAULT AND EXCHANGED THEIR CONTROLLER ON THEIR OWN. THE PATIENT THEN RECEIVED A NEW PRIMARY AND BACKUP SYSTEM CONTROLLER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE SERIAL NUMBER OF THE SYSTEM CONTROLLER THE PATIENT EXCHANGED, IF THE CAUSE OF THE ALARMS WAS IDENTIFIED, IF THE ALARMS RESOLVED, IF ANY ADDITIONAL TROUBLESHOOTING WAS PERFORMED, IF ANY PRODUCT WILL BE RETURNED; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AND TO DATE, NO SYSTEM CONTROLLER HAS BEEN RECEIVED FOR FURTHER ANALYSIS. THE SUBMITTED LOG FILE WAS REVIEWED AND DID NOT CAPTURE ANY YELLOW WRENCH ALARMS THAT WOULD HAVE BEEN DISPLAYED TO THE PATIENT ON THE SYSTEM CONTROLLER. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED DUE TO THE SERIAL NUMBER OF THE HEARTMATE II SYSTEM CONTROLLER NOT BEING REPORTED. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE II LVAS IFU, REV. A, HEARTMATE II PATIENT HANDBOOK, REV. A ARE CURRENTLY AVAILABLE. SECTION 7 OF THE IFU, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INSTRUCTION ON HOW TO IDENTIFY AND TROUBLESHOOT YELLOW WRENCH ALARMS, INCLUDING THOSE ASSOCIATED WITH CLOCK NOT SET FLAGS. THIS SECTION ALSO NOTES THE YELLOW WRENCH ALARMS ASSOCIATED WITH CLOCK NOT SET FLAGS WILL ONLY DISPLAY ON THE HEARTMATE TOUCH AND WILL NOT DISPLAY ON THE SYSTEM CONTROLLER. SECTION 8 OF THE IFU, ENTITLED ¿EQUIPMENT STORAGE AND CARE¿, PROVIDES INSTRUCTION ON HOW TO CARE FOR AND MAINTAIN THE SYSTEM CONTROLLER. SECTION 2 OF THE IFU, ENTITLED ¿SYSTEM OPERATIONS¿, PROVIDES INSTRUCTION ON HOW TO EXCHANGE THE CONTROLLER AND ADVISES THE USER TO HAVE A CAREGIVER PRESENT DURING A SYSTEM CONTROLLER EXCHANGE AND/OR TO CALL A HOSPITAL CONTACT IF INSTRUCTED. 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 STATED THEY EXPERIENCED A SYSTEM CONTROLLER FAULT AND EXCHANGED THEIR SYSTEM CONTROLLER WITHOUT NOTIFYING CLINICIANS. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED LOW SPEED ADVISORIES, DRIVELINE FAULTS AND PUMP STOPS. THIS TYPE OF BEHAVIOR HAS BEEN LINKED TO POTENTIAL ISSUES WITH THE PERCUTANEOUS LEAD. THESE ISSUES ONLY APPEARED TO BE OCCURRING WHILE THE VENTRICULAR ASSIST DEVICE (VAD) WAS CONNECTED TO THE MOBILE POWER UNIT (MPU). ACCORDING TO RECORDS, THIS PATIENT HAD A DRIVELINE REPAIR ON (B)(6) 2025 (B)(6) AND SHOULD HAVE BEEN USING A POWER MODULE WITH AN UNGROUNDED CABLE, OR BATTERIES. THE LOG FILES WERE SUBMITTED FOR REVIEW AND CONFIRMED THAT THE MPU WAS IN USE AT THE TIME OF THE EVENT. IT WAS LATER REPORTED BY INTENSIVE CARE UNIT STAFF THAT THE PATIENT EXPERIENCED SYSTEM CONTROLLER FAULT ALARMS AROUND 22:30 WITH AS THE FLOW ON (B)(6) 2026, PT CAME IN "UNSTABLE" LABS REQUIRING THE PATIENT BE PLACED ON EMERGENT DIALYSIS WITH VASOPPRESSIVE DRUGS FOR SUPPORT. THIS SYSTEM CONTROLLER (PCK -21412) WAS JUST CHANGED/ADDED TO THE PATIENT 6 DAYS AGO, LAST WEEK. ADDITIONAL LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED THE INTERNAL CLOCK NOT SET AND SHOWS DEFAULT DATE/TIME OF (B)(6) 2001 AT 0100. ALSO NOTED MULTIPLE LOW SPEED AND PUMP OFF EVENTS THROUGHOUT THE LOG ON BOTH MPU AND BATTERY POWER AS WELL AS INTERMITTENT DRIVELINE FAULT EVENTS. THE DRIVELINE WIRE IMPEDANCE FOR THE DRIVELINE FAULT ALGORITHM VALUES SHOW THE ORANGE (PHASE 3) AND THE YELLOW (PHASE 1) WIRE HAVING CONTINUITY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175714 THORATEC® HEARTMATE II®, SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male