BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1236808 · Received November 5, 2008

    Report

    Report Number
    1527821-2008-00012
    Event Type
    Other
    Date Received
    November 5, 2008
    Date of Event
    April 1, 2008
    Report Date
    November 5, 2008
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE STERIS'S INQUIRIES, THE FACILITY HAS NOT PROVIDED ADDITIONAL INFO ABOUT THE ALLEGED INCIDENT, INCLUDING ANY DETAILS ABOUT THE LEVEL, EXTENT, AND/OR SERIOUSNESS OF THE REPORTED INJURY. THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS CONTAINED IN STERIS'S OPERATOR MANUAL AND IN-SERVICE TRAINING, WHICH DIRECT THAT PROPER PPE MUST BE WORN WHEN HANDLING OPEN OR UNUSED CONTAINERS OF S20. FURTHERMORE, THE OPERATOR FAILED TO FOLLOW THE S20 PRODUCT LABELING (AS WELL AS THE OPERATOR MANUAL AND TRAINING INSTRUCTIONS), WHICH CLEARLY STATE THAT IF S20 COMES INTO CONTACT WITH THE SKIN, ONE SHOULD RINSE THE SKIN IMMEDIATELY WITH LARGE AMOUNTS OF WATER AND SEEK MEDICAL ATTENTION. STERIS WILL CONTINUE TO WORK WITH THIS HOSP TO ASSURE THAT ITS SYSTEM 1 USERS UNDERSTAND THE PROPER METHODS FOR SAFE HANDLING OF S20.

    Description of Event or Problem · 1

    THE HOSPITAL BIO MED DEPARTMENT REPORTED TO A STERIS SERVICE TECHNICIAN, THAT AN EMPLOYEE RECEIVED A CHEMICAL BURN TO THE BACK OF HER HAND IN 2008. ACCORDING TO THE BIO MED DEPARTMENT, A STERIS SYSTEM 1 STERILIZER EXPERIENCED A POWER FAILURE AFTER A CYCLE WAS STARTED. THE OPERATOR OPENED THE SYSTEM 1 LID AND ATTEMPTED TO REMOVE THE UNUSED STERIS 20 STERILANT CONCENTRATE (S20) CUP, WHICH CONTAINS 35% PERACETIC ACID. IN THE PROCESS OF REMOVING THE S20 CONTAINER, THE OPERATOR SPLASHED STERILANT ONTO THE BACK OF HER HAND. SHE WAS NOT WEARING ANY PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE INCIDENT. INSTEAD OF RINSING THE AFFECTED AREA WITH WATER AS DIRECTED IN THE STERIS LABELING, THE OPERATOR USED RUBBING ALCOHOL TO RINSE THE AFFECTED AREA OF HER HAND. THE HOSPITAL BIO MED DEPARTMENT SERVICED THE UNIT POST-INCIDENT, AND THERE HAVE BEEN NO FURTHER POWER FAILURE ISSUES WITH THE DEVICE SINCE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 LOW TEMPERATURE STERILIZERS MLR STERIS CORPORATION 4544721 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other