BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 16372448 · Received February 14, 2023

    Report

    Report Number
    2916596-2023-00979
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    February 8, 2023
    Report Date
    March 31, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF AN CONNECT POWER ALARMS APPEARING ON THE SYSTEM CONTROLLER WAS UNABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) WAS NOT RETURNED FOR ANALYSIS AND NO LOG FILES WERE SUBMITTED FOR REVIEW. MULTIPLE GOOD FAITH EFFORTS WERE SENT REGARDING PRODUCT RETURN. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF THE PRODUCT IS RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE REOPENED. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: HSC-120735) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE III INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING POWER CABLE DISCONNECT ALARMS. HEARTMATE III INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 "CARING FOR THE EQUIPMENT" DESCRIBES HOW TO CARE FOR AND CLEAN ALL EQUIPMENT INCLUDING THE SYSTEM CONTROLLER POWER CABLES AND POWER CABLE CONNECTORS. HEARTMATE III PATIENT HANDBOOK AND HEARTMATE III INSTRUCTIONS FOR USE (IFU) UNDER SECTION 3, ENTITLED ¿POWERING THE SYSTEM¿, DESCRIBES THE VARIOUS WAYS TO POWER THE HEARTMATE II LVAS. THESE SECTIONS EXPLAIN HOW TO PROPERLY SWITCH BETWEEN POWER SOURCES. HEARTMATE III PATIENT HANDBOOK AND HEARTMATE III INSTRUCTIONS FOR USE (IFU) CAUTION 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE WAITING FOR IMPLANT AFTER PUMP PRIMING, ALTHOUGH THE SYSTEM CONTROLLER WAS PROPERLY CONNECTED TO THE POWER MODULE AN ALARM STATING "PLEASE CONNECT THE SYSTEM CONTROLLER WITH POWER MODULE" APPEARED ON THE HEARTMATE TOUCH. THE CONNECTION WAS CHECKED AND WHILE EXCHANGING THE POWER MODULE A CONTROLLER FAULT ALARM OCCURRED. THE SYSTEM CONTROLLER WAS REPLACED AND THERE WAS NO IMPACT TO THE ONGOING IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964195 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531INT 8763432

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown