BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE SYSTEM MONITOR

    MDR report key: 9538869 · Received January 2, 2020

    Report

    Report Number
    2916596-2019-05981
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    December 17, 2019
    Report Date
    April 24, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010654
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G4: PMA/510(K) # P060040; P160054.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE PUMP OFF AND LOW FLOW ALARM ON THE SYSTEM MONITOR WAS CONFIRMED WITH THE SUBMITTED REFERENCE PHOTO ON (B)(6) 2019. THE REFERENCE PHOTO REVEALED THE ALARMS WERE ACTIVE, HOWEVER; THE INFORMATION ON SCREEN INDICATED THE SYSTEM IS OPERATING AT 5,500 RPM WITH A FLOW OF 4.9 LPM. THE DATA CAPTURED IN THE LOG FILE CONFIRMED THE SYSTEM OPERATED AT THESE VALUES WITHOUT THE HAZARD ALARMS. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 19, 2019 RECOMMENDED A REBOOT, WHICH SOLVED THE ISSUE. THE SYSTEM MONITOR IS NOT EXPECTED TO BE RETURNED FOR AN EVALUATION. ALL AVAILABLE INFORMATION FOR CONDUCTING THIS INVESTIGATION WAS COLLECTED AND NO ADDITIONAL FOLLOW-UP ATTEMPTS WILL BE PERFORMED. TO DATE, THE SYSTEM MONITOR (SERIAL#: UNAVAILABLE) ASSOCIATED WITH THE EVENT WAS UNAVAILABLE FOR AN EVALUATION. THE COMPLAINT FILE WILL CLOSE ACCORDINGLY AND WILL BE REOPENED IF PERTINENT INFORMATION IS RECEIVED. 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER MODULE DISPLAYED PUMP OFF AND LOW FLOW ALARMS, ALTHOUGH THE PUMP WAS RUNNING WITH NORMAL PARAMETERS. THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE POWER MODULE WAS UNPLUGGED AND RESTARTED AND THIS RESOLVED THE ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309 HEARTMATE SYSTEM MONITOR VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 1286C 7052745 00813024010654

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention