BEUDAMED
    FDA Adverse Event Summary report: N

    V-PRO STERILIZER

    MDR report key: 3053568 · Received April 11, 2013

    Report

    Report Number
    3005899764-2013-00031
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    MLR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS CLINICAL EDUCATION SPECIALIST, SERVICE TECHNICIAN AND SERVICE SPECIALIST INSPECTED THE USER FACILITY'S V-PRO UNIT AND OBSERVED THE PROCEDURAL PRACTICES OF THE FACILITY. THE SERVICE TECHNICIAN FOUND THE UNIT TO BE OPERATING PROPERLY; THE CLINICIAN CONFIRMED THAT THE FACILITY'S PRACTICES WERE APPROPRIATE AND COMPATIBLE WITH THE V-PRO STERILIZER. THE CLINICIAN ALSO ADDRESSED THE IMPORTANCE OF WEARING PROPER PPE WHILE WORKING WITH THE V-PRO STERILIZER, AS ALL THREE EMPLOYEES INVOLVED WERE NOT WEARING PROPER PPE (GLOVES) AT THE TIME OF THE REPORTED EVENT. THE OPERATOR MANUAL STATES (2-1), "PPE- PERSONAL PROTECTIVE EQUIPMENT INCLUDING GOGGLES OR FACE SHIELD AND CHEMICAL-RESISTANT GLOVES. PPE REQUIRED PER TASK WILL VARY DEPENDING UPON HAZARDS OF THE TASK." A STERIS FIELD SERVICE ENGINEER AND FIELD SERVICE TECHNICIAN PERFORMED A FOLLOW UP VISIT TO THE USER FACILITY AS THE FACILITY REPORTED CONCERNS REGARDING THE "LOAD TEST REPEATED" MESSAGE PRINTED ON CYCLE TAPES. THE STERIS ENGINEER STRESSED TO THE FACILITY THAT THE "LOAD TEST REPEATED" MESSAGE DOES NOT INDICATE A CYCLE FAIL. A "LOAD TEST REPEATED" MESSAGE MAY OCCUR IF INSTRUMENTS ARE NOT PROPERLY DRIED BEFORE BEING PLACED INTO THE PACKS. THE STERIS ENGINEER PROVIDED TRAINING TO THE USER FACILITY STAFF ON PROPER INSTRUMENT LOADING PRACTICES, INCLUDING HOW TO PROPERLY DRY INSTRUMENTS BEFORE PROCESSING. NO ADDITIONAL ISSUES WERE REPORTED AFTER THE USER FACILITY RECEIVED IN-SERVICE TRAINING ON THE PROPER METHOD FOR DRYING AND LOADING INSTRUMENTS INTO THE V-PRO UNIT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THERE WAS RETAINED HYDROGEN PEROXIDE IN A PACKAGE THAT WAS REMOVED FROM THE V-PRO STERILIZER. THE FACILITY REPORTED THAT 3 EMPLOYEES RECEIVED HYDROGEN PEROXIDE BURNS THEIR HANDS WHILE HANDLING A PACKAGE FROM THE V-PRO STERILIZER. THE FIRST EMPLOYEE WAS MOVING THE PACKAGE AND NOTICED A CLEAR FLUID SEEP ONTO HIS HAND. HE THEN NOTICED A BURNING SENSATION AND WASHED THE AREA WITH WATER. AT THIS TIME, A SECOND EMPLOYEE ENTERED THE ROOM, OPENED THE PACKAGE AND NOTICED A CLEAR LIQUID. THE SECOND EMPLOYEE THEN PLACED HIS FINGER IN THE SUBSTANCE TO ASCERTAIN WHAT THE LIQUID WAS. THE SECOND EMPLOYEE THEN NOTICED A BURNING SENSATION AND BEGAN WASHING HIS HAND. A THIRD EMPLOYEE THEN ENTERED THE ROOM AND BEGAN CLEANING AND DISPOSING OF THE PACKAGE. DURING THE CLEANING, THE THIRD EMPLOYEE CAME IN CONTACT WITH THE LIQUID AND NOTICED A BURNING SENSATION. THE AFFECTED AREAS OF ALL THREE PERSONNEL TURNED WHITE; HOWEVER, THERE WAS NO REPORT OF BLISTERING WITH THE BURN. THE EMPLOYEES RAN WATER OVER THE AFFECTED AREA AND WERE SENT TO EMPLOYEE HEALTH TO HAVE THE BURNS CHECKED. NO TREATMENT WAS ADMINISTERED AND THE EMPLOYEES RETURNED TO WORK WITH NO WORK TIME MISSED. TWO PROCEDURAL DELAYS WERE REPORTED DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155016 V-PRO STERILIZER STERILIZER MLR STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1