BEUDAMED
    FDA Adverse Event Summary report: N

    V-PRO MAX STERILIZER

    MDR report key: 4102791 · Received September 19, 2014

    Report

    Report Number
    3005899764-2014-00089
    Date Received
    September 19, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 19, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    MLR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMPLOYEE INJURED SOUGHT MEDICAL ATTENTION AT THE ER AND WAS GIVEN OINTMENT AND BANDAGES. THE EMPLOYEE WAS ABLE TO RESUME WORK AFTER TREATMENT. THE STERIS FIELD SERVICE TECHNICIAN REPORTED THAT THE BURN WAS NOT CAUSED BY A FAILURE OF THE UNIT AND THAT THE UNIT IS WORKING ACCORDING TO SPECIFICATIONS. THE STERIS FIELD SERVICE TECHNICIAN ADVISED THE USER FACILITY STAFF TO THOROUGHLY CLEAN, RINSE, DRY, AND INSPECT LOADS FOR MOISTURE PRIOR TO WRAPPING PER THE OPERATOR MANUAL. THE OPERATOR MANUAL (1-2) STATES, "FAILURE TO THOROUGHLY CLEAN, RINSE, AND DRY ARTICLES TO BE STERILIZED COULD RESULT IN AN INEFFECTIVE STERILIZATION CYCLE." THE OPERATOR MANUAL (6-11) STATES, "UNLOAD STERILIZATION UNIT: STERIS RECOMMENDS (IN ACCORDANCE WITH ANSI/AAMI ST58, 2005) WEARING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT. IN ADDITION, THE OPERATOR MANUAL (1-2) STATES, "DANGER - CHEMICAL INJURY HAZARD: ANY VISIBLE LIQUIDS IN THE CHAMBER MUST BE TREATED AS CONCENTRATED HYDROGEN PEROXIDE. OBSERVE ALL HYDROGEN PEROXIDE HANDLING PRECAUTIONS."

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE OPERATOR OF A VPRO MAX RECEIVED A BURN WHEN UNLOADING THE STERILIZER. NO PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584608 V-PRO MAX STERILIZER STERILIZER MLR STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other