BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 24120921 · Received January 20, 2026

    Report

    Report Number
    2916596-2026-00447
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    December 30, 2025
    Report Date
    March 31, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    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

    MANUFACTURER¿S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW SPEED EVENTS, PUMP STOP EVENTS, AND SILENCED DRIVELINE FAULT ALARMS, CONSISTENT WITH SUSPECTED DRIVELINE WIRE DAMAGE. A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED PATIENT CONDITION AND NEED FOR TREATMENT COULD NOT BE CONCLUSIVELY ESTABLISHED. THE PATIENT REPORTED A CONTROLLER FAULT, SO THEY EXCHANGED THEIR CONTROLLER. THE PATIENT CAME IN WITH ¿UNSTABLE¿ LABS REQUIRING EMERGENT DIALYSIS WITH VASOPRESSIVE DRUGS (BLOOD PRESSURE SUPPORT MEDICATION) FOR SUPPORT. THE INTENSIVE CARE UNIT STAFF REPORTED CONTROLLER FAULT ALARMS WITH ¿---¿ ON (B)(6) 2026. RELEVANT DATA IN THE SUBMITTED LOG FILES WAS REVIEWED AND FOUND THAT THE CONTROLLER CLOCK WAS NOT SET FOR MOST OF THE CAPTURED EVENTS. INTERMITTENT, SILENCED DRIVELINE FAULT ALARMS WERE CAPTURED, WHICH APPEARED TO BE ASSOCIATED WITH POTENTIAL ISSUES ON THE ORANGE AND YELLOW WIRES. LOW SPEED AND PUMP STOP EVENTS WERE INTERMITTENTLY CAPTURED WHILE THE DEVICE WAS CONNECTED TO THE MOBILE POWER UNIT (MPU), 14-VOLT BATTERIES, OR THE POWER MODULE. THESE EVENTS WERE ASSOCIATED WITH LOW-SPEED ADVISORY, LOW SPEED HAZARD, LOW FLOW HAZARD, TIME BASE FAULT, AND MOTOR STOP ALARM FLAGS. BASED ON HISTORICAL EXPERIENCE WITH THE HEARTMATE II LVAS AND SIMILAR REPORTED EVENTS, THESE EVENTS COULD BE INDICATIVE OF AN ISSUE WITH THE DRIVELINE. THERE WERE NO OTHER NOTABLE FINDINGS RELATED TO THE PUMP. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE SUBMITTED TO THE ACCOUNT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THE PATIENT REMAINS ONGOING ON (B)(6) WITH NO FURTHER REPORTED ISSUES AT THIS TIME. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CONTAIN INFORMATION ON CARING FOR THE DRIVELINE, POSSIBLE INDICATIONS OF DRIVELINE DAMAGE, AND HOW TO RESPOND TO SUCH EVENTS. THES DOCUMENTS OUTLINE SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO ALARM CONDITIONS. THE IFU PROVIDES EXPLANATION OF ALL PUMP PARAMETERS AND EXPLAINS THAT ¿---¿ IS DISPLAYED WHEN THE PUMP IS STOPPED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AND THE DRIVELINE, SERIAL NUMBER (B)(6) AND (B)(6), WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. A, IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS, INCLUDING RENAL FAILURE. SECTION 1 ALSO PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING PUMP SPEED, FLOW, AND POWER. SECTION 4 ¿HEARTMATE TOUCH COMMUNICATION SYSTEM¿ PROVIDES MORE INFORMATION REGARDING ALL PUMP PARAMETERS. THIS SECTION EXPLAINS THAT ¿---¿ IS DISPLAYED WHEN THE PUMP IS STOPPED. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ DISCUSSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. THIS SECTION ALSO CONTAINS INFORMATION ON ¿CARING FOR THE DRIVELINE¿ (UNDER ¿ONGOING SYSTEM ASSESSMENT AND CARE¿) AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. SECTION 7 "ALARMS AND TROUBLESHOOTING" OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ ALSO CONTAINS INFORMATION ON ¿CARE OF THE DRIVELINE,¿ AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE. THE HEARTMATE II LVAS PATIENT HANDBOOK, REV. A, IS ALSO CURRENTLY AVAILABLE. SECTION 4 ¿LIVING WITH THE HEARTMATE II¿ CONTAINS INFORMATION ON CARING FOR THE DRIVELINE. DAMAGE TO THE DRIVELINE MAY CAUSE THE PUMP TO STOP. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 6 "CARING FOR THE EQUIPMENT" DISCUSSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE AND OUTLINES INDICATIONS OF DRIVELINE DAMAGE, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU 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 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 (CS-219371) 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 VASOPRESSIVE 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
    552236 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Life Threatening| H| O| R