BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 18046429 · Received November 1, 2023

    Report

    Report Number
    2916596-2023-07432
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 11, 2023
    Report Date
    May 24, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SECTION D3, G1: UPDATED INFORMATION. SECTION D1: CORRECTED. SECTION D4, CATALOG NUMBER: CORRECTED. SECTION D4, PRIMARY UDI NUMBER: CORRECTED. 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 A DIM PUMP RUNNING LIGHT EMITTING DIODE (LED) COULD NOT BE CONFIRMED AS THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) WAS NOT RETURNED FOR ANALYSIS. THE SUBMITTED LOG FILE CONTAINED INFORMATION SPANNING APPROXIMATELY 4 DAYS (B)(6) 2023 TO (B)(6) 2023PER TIMESTAMP). OCCASIONALLY THROUGHOUT THE DATA, LOW POWER ADVISORY ALARMS WERE OBSERVED; HOWEVER, THEY DID NOT APPEAR TO BE ABNORMAL. IT APPEARED THAT THE PATIENT FREQUENTLY CONNECTED TO 14V BATTERIES THAT WERE NOT FULLY CHARGED. THESE BATTERIES THEN DEPLETED NORMALLY AND MAY HAVE REACHED THE LOW VOLTAGE ALARM THRESHOLD SOONER THAN THE PATIENT MAY HAVE EXPECTED. THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE DATA. AVAILABLE INFORMATION INDICATED THAT THE HEARTMATE 3 SYSTEM CONTROLLER WAS EXCHANGED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE TROUBLESHOOTING PERFORMED AND THE RESOLUTION OF THE REPORTED ALARMS, BUT NO RESPONSE WAS RECEIVED. THE ROOT CAUSES OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D - SECTION 6 ¿CARING FOR THE EQUIPMENT¿) DESCRIBES HOW TO PROPERLY CARE FOR AND CLEAN ALL 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. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THAT THE HEARTMATE 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(6) , WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 2 GREEN ARROWS ON THE CONTROLLER WERE EXTREMELY DIM AND DIFFICULT TO SEE. THE CONTROLLER (B)(6) WAS EXCHANGED, AND NEW BACKUP CONTROLLER WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141895 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7403889 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male