BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 20228591 · Received September 16, 2024

    Report

    Report Number
    2916596-2024-06007
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 29, 2024
    Report Date
    December 6, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BLANK DISPLAY ON THE SYSTEM CONTROLLER WAS UNABLE TO BE CONFIRMED. THE SYSTEM CONTROLLER (SERIAL NUMBER: HSC-121543) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, LOG FILES WERE SUBMITTED AND DATA FROM THE REPORTED EVENT DATE OF 29AUG2024 WAS REVIEWED. THERE WERE NO OTHER NOTABLE EVENTS ACTIVE IN THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED. MULTIPLE GOOD FAITH EFFORTS WERE SENT IN ATTEMPT TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE CAUSE OF THE BLANK SCREEN AND IF THE SYSTEM CONTROLLER WOULD BE RETURNED FOR ANALYSIS; HOWEVER, NO RESPONSE WAS RECEIVED. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C), UNDER SECTION 2 ¿SYSTEM OPERATIONS¿ EXPLAIN THE SYSTEM CONTROLLER USER INTERFACE, INCLUDING THE DISPLAY SCREEN AND ALL BUTTONS, LIGHTS, AND SYMBOLS. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 6 "CARING FOR THE EQUIPMENT" AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION 8 "EQUIPMENT STORAGE AND CARE" DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 10 AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION F, BOTH ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 PATIENT HANDBOOK (REV. D) CAUTIONS 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. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL NUMBER: HSC-121543) AND IT WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. 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 A NEW PUPPY ACCIDENTALLY CHEWED ON THE MODULAR CABLE AND THE SYSTEM CONTROLLER ALARMED DRIVELINE POWER FAULT, PER PATIENT'S MOTHER. SINCE THE PATIENT HAD A BIVENTRICULAR ASSIST DEVICE (BIVAD), THEY WERE INSTRUCTED TO COME TO HOSPITAL. THE MODULAR CABLE WAS EXCHANGED SUCCESSFULLY, AND THE ALARM RESOLVED. THE MODULAR CABLE WOULD BE RETURNED FOR ANALYSIS. THE PATIENT PLANNED TO BE DISCHARGED HOME. ADDITIONAL INFORMATION STATED THAT SYSTEM CONTROLLER WAS EXCHANGED DUE TO AN APPARENT BLANK SCREEN. LOG FILES DISPLAYED MULTIPLE STRINGS OF CONTROLLER CLOCK CORRUPT ALARMS. ADDITIONAL LOG FILES SHOWED A STRING OF LOW FLOW / DRIVELINE DISCONNECT / LVAD OFF ALARMS ON 03SEP2024 AT ~1:54 AM ASSOCIATED WITH A SYSTEM CONTROLLER EXCHANGE AS MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482669 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8745998 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female