BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELIMED STEAM STERILIZER MST-H TOP 5000

    MDR report key: 11712805 · Received April 23, 2021

    Report

    Report Number
    3001061128-2021-00005
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    June 4, 2018
    Report Date
    April 22, 2021
    Manufacturer
    BELIMED AG
    Product Code
    FLE
    PMA / PMN Number
    K170228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INITIAL INSTALLATION OF THE DEVICE AT A HEALTHCARE FACILITY, THE TECHNICIAN IN CHARGE INTENDED TO PROGRAM A PREVACUUM CYCLE BASED ON USER-SPECIFIED PARAMETERS. HE ENTERED THE PARAMETERS AND RENAMED THE PROGRAM TO IDENTIFY THE PREVACUUM CYCLE. HOWEVER, HE FAILED TO SAVE THE CHANGED PARAMETERS AND THE PROGRAM REVERTED TO THE ORIGINAL GRAVITY CYCLE PARAMETERS. THUS, WHENEVER THE SUPPOSEDLY PREVACUUM PROGRAM WAS RUN, A GRAVITY CYCLE WAS EXECUTED. THE PROGRAM WAS USED OCCASIONALLY FROM (B)(6) 2018 THROUGH (B)(6) 2019. SEVEN STERILIZERS WERE INSTALLED AT THE AFFECTED HEALTHCARE FACILITY AT THE TIME UNDER THE SUPERVISION OF THE SAME TECHNICIAN. FOUR OF THE STERILIZERS WERE AFFECTED BY A SIMILAR PROBLEM. THIS IS MEDICAL DEVICE REPORT NUMBER TWO OF FOUR. THE PROGRAMMING ERROR HAS BEEN CORRECTED AND THE PROGRAM IS RUNNING PROPERLY. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED.

    Description of Event or Problem · 1

    A USER-SPECIFIED PREVACUUM STERILIZATION CYCLE WAS INCORRECTLY PROGRAMMED BY THE TECHNICIAN DURING INITIAL INSTALLATION OF THE STERILIZER. THE PROGRAM RAN A GRAVITY CYCLE WITH ADDITIONAL STERILIZATION HOLD TIME. DEVICE STERILIZATION WAS ENSURED, BUT THE ERROR REPEATEDLY RESULTED IN WET PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614502 BELIMED STEAM STERILIZER MST-H TOP 5000 STEAM STERILIZER FLE BELIMED AG GR 9-6-15 HS2 25178

    Patients

    Seq Age Sex Outcome Treatment
    1