BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 18221069 · Received November 28, 2023

    Report

    Report Number
    2916596-2023-08011
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    June 22, 2022
    Report Date
    May 29, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE SERIAL NUMBER WAS NOT PROVIDED, INQUIRY FOR THIS INFORMATION HAS BEEN MADE. USER FACILITY REPORT: 3400300000-2022-0000040 WAS RECEIVED 08NOV2023.   NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF ALARMS WAS NOT ABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: UNKNOWN) WAS NOT RETURNED FOR ANALYSIS AND NO LOG FILES WERE SUBMITTED FOR REVIEW. PROVIDED INFORMATION INDICATED THAT THE PATIENT EXCHANGED THEIR CONTROLLER IN RESPONSE TO THE ALARMS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT, BUT NO RESPONSE WAS RECEIVED. THE ROOT CAUSE OF THE REPORTED ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE SERIAL NUMBER OF THE EQUIPMENT WAS NOT PROVIDED. THE HEARTMATE 3 PATIENT HANDBOOK (REV D - SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿) EXPLAINS HOW TO PROPERLY REPLACE THE RUNNING SYSTEM CONTROLLER WITH A BACKUP SYSTEM CONTROLLER. THE PATIENT IS CAUTIONED TO NOT ATTEMPT A SYSTEM CONTROLLER EXCHANGE WITHOUT HAVING A TRAINED, COMPETENT CAREGIVER AT THEIR SIDE. THE HEARTMATE 3 PATIENT HANDBOOK (REV D - SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) COVERS ALL ALARMS (VISUAL AND AUDIBLE), AND THE ACTIONS TO TAKE IF THE ALARM CANNOT BE RESOLVED. THE HEARTMATE 3 PATIENT HANDBOOK (REV D - SECTION 6 ¿CARING FOR THE EQUIPMENT¿) DESCRIBES HOW TO PROPERLY CARE FOR ALL HEARTMATE EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER AND ITS POWER CABLES. THE PATIENT HANDBOOK CAUTIONS THE USER 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

    RELATED MANUFACTURER REFERENCE NUMBER: (B)(4) (MODULAR CABLE). A USER FACILITY MEDWATCH WAS RECEIVED THAT STATES THAT PATIENT CALLED VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR DUE TO CONTROLLER ALARMS WHILE AT HOME. VAD COORDINATOR INSTRUCTED PATIENT TO CHANGE OUT THEIR CONTROLLER FOR THEIR BACKUP CONTROLLER. THE PATIENT ARRIVED AT CLINIC ON (B)(6) 2022 WITH NOTED DAMAGE TO MODULAR CABLE. MODULAR CABLE WAS REPLACED. DAMAGE ALSO WAS NOTED TO DRIVELINE AT THE BEND RELIEF ABOVE THE CONNECTOR. BEND RELIEF TEAR WAS REPAIRED WITH RESCUE TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602447 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female