BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 19623375 · Received June 27, 2024

    Report

    Report Number
    2916596-2024-03864
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 22, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION D4, EXPIRATION DATE, PRIMARY UDI NUMBER: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A VERTICAL LINE IN THE SYSTEM CONTROLLER LIQUID CRYSTAL DISPLAY (LCD) WAS CONFIRMED. THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS RETURNED FOR ANALYSIS. THE LCD HAD A VERTICAL WHITE LINE WHICH DID NOT AFFECT THE CONTROLLER¿S ABILITY TO DISPLAY READABLE MESSAGES. FOLLOWING PRELIMINARY TESTING, THE LCD SCREEN FROM THE CONTROLLER WAS SWAPPED WITH A FUNCTIONAL ONE. THIS RESOLVED THE LINES IN LCD ISSUE. THE CONTROLLER UNDERWENT FUNCTIONAL TESTING AND PASSED. NO ATYPICAL ALARMS WERE PRODUCED DURING TESTING. THE CONTROLLER WAS ABLE TO SUPPORT PUMP FUNCTION FOR EXTENDED PERIOD OF TIME. THE ROOT CAUSE FOR THE REPORTED SCREEN ISSUE WAS CONCLUSIVELY DETERMINED TO BE DUE TO AN ISSUE WITH THE THIN FILM TRANSISTORS OF THE LCD BEING SHORTED ON. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PATIENT HANDBOOK AND IFU ALSO 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. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 8-¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 6-¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY TAKE CARE AND MAINTAIN THE INTEGRITY OF THE SYSTEM CONTROLLER. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D), SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿ STATES ¿DO NOT ATTEMPT TO CHANGE YOUR SYSTEM CONTROLLER WITHOUT HAVING A TRAINED, COMPETENT CAREGIVER AT YOUR SIDE TO ASSIST. FOLLOW ALL ALARM INSTRUCTIONS, INCLUDING CALLING THE HOSPITAL.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT'S SYSTEM CONTROLLER HAD A LINE DOWN IN THE MIDDLE OF THE SCREEN. THE SYSTEM CONTROLLER WAS THEN EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697330 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8234290 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male