BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 12336902 · Received August 18, 2021

    Report

    Report Number
    2916596-2021-04235
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 19, 2021
    Report Date
    November 24, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT THAT THE BACKUP BATTERY RIBBON CABLE WAS DETACHED WAS CONFIRMED. VISUAL INSPECTION REVEALED THAT THE BACKUP BATTERY RIBBON CABLE WAS DETACHED FROM THE PCB CONNECTOR. THE RETAINING CLIP THAT HOLDS THE RIBBON CABLE TO THE PCB BOARD WAS MISSING. THE INVESTIGATION DID NOT CONFIRM ANY FUNCTIONAL ISSUES WITH THE RETURNED SYSTEM CONTROLLER HSC-102358 WHEN THE RIBBON CABLE AND THE RETURNED BACKUP BATTERY GV111387 WERE RE-INSERTED TO THE CONTROLLER'S BACKUP BATTERY CONNECTOR. THE RETURNED SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED DURING ANALYSIS. THE RETURNED DEVICE SUPPORTED A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY ATYPICAL ALARMS OR EVENTS BEING CAPTURED. BASED ON EVALUATION RESULTS, THE ROOT CAUSE OF THE DETACHED BACKUP BATTERY RIBBON CABLE APPEARS TO BE A MISSING RETAINING CLIP THAT HOLDS THE RIBBON CABLE TO THE CONTROLLER'S PC BOARD. A MANUFACTURING INVESTIGATION WAS OPENED TO ADDRESS MISSING RETAINING CLIP THAT HOLDS THE BACKUP BATTERY RIBBON CABLE TO THE PCB BOARD AND IT WAS DETERMINED THAT MISSING RETAINING CLIP WAS MANUFACTURING RELATED AND THE OPERATORS WERE RE-TRAINED. DEVICE HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO MFG AND QA SPECIFICATIONS. SYSTEM CONTROLLER SERIAL # (B)(6) WAS SHIPPED TO THE CUSTOMER ON 18JUL2021. HEARTMATE 3 PATIENT HANDBOOK REV B, CAUTIONS THE USERS TO ¿CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. YOUR HOSPITAL CONTACT CAN CHECK THE EQUIPMENT AND ORDER REPLACEMENTS, IF NEEDED. DO NOT TRY TO REPAIR ANYTHING YOURSELF.¿ HEARTMATE 3 INSTRUCTIONS FOR USE REV C, ¿REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN¿. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BACKUP BATTERY RIBBON WAS COMPLETELY DETACHED. THE SYSTEM CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233562 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531US 7987126 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female