BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 16717126 · Received April 11, 2023

    Report

    Report Number
    2916596-2023-01798
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    August 5, 2022
    Report Date
    April 11, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED MANUFACTURE¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A CONTROLLER EXCHANGE WAS CONFIRMED VIA ANALYSIS OF THE SUBMITTED LOG FILES. THE HEARTMATE 3 SYSTEM CONTROLLER WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED. THE SUBMITTED CONTROLLER PERIODIC LOG FILE CONTAINED COMBINED DATA SPANNING APPROXIMATELY 320 DAYS (B)(6) 2022 ¿ (B)(6) 2023 PER THE TIMESTAMP) AND THE SUBMITTED LVAD PERIODIC LOG FILE CONTAINS DATA SPANNING APPROXIMATELY 254 DAYS (B)(6) 2022 - (B)(6) 2023 PER THE TIMESTAMP). A REVIEW OF THE SYSTEM CONTROLLER AND LVAD PERIODIC LOG FILES REVEALED THAT THE PUMP WAS NOT CONNECTED TO THE CONTROLLER FROM THESE LOG FILES (HSC-063166) UNTIL (B)(6) 2022 DESPITE THE PUMP HAVING BEEN SUPPORTING THE PATIENT SINCE AT LEAST (B)(6) 2022 (THE PATIENT WAS IMPLANTED ON (B)(6) 2019). THESE FINDINGS APPEAR TO SUGGEST THAT A CONTROLLER EXCHANGE WAS LIKELY PERFORMED ON (B)(6) 2022. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT SUCH AS WHY A CONTROLLER EXCHANGE WAS PERFORMED AND IF ANY PRODUCT IS RETURNING FOR ANALYSIS; HOWEVER, NO RESPONSE WAS GIVEN. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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, AND THE ACTIONS TO TAKE IF THE ALARMS DO NOT RESOLVE THE PATIENT HANDBOOK 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REVIEW OF THE SYSTEM CONTROLLER LOG FILES REVEALED THAT A CONTROLLER EXCHANGE WAS LIKELY PERFORMED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623880 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male