BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3250086 · Received July 26, 2013

    Report

    Report Number
    3000251274-2013-00065
    Date Received
    July 26, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 26, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE HOSE HAD SEPARATED AT A STRAIGHT FACTORY CRIMPED FITTING TO THE A/B PRE-FILTER. THE TECHNICIAN REPLACED ALL HOSES AND RETURNED THE UNIT TO SERVICE. THE TECHNICIAN SENT ALL HOSES BACK TO STERIS QUALITY FOR EVALUATION. THE HOSE SUBJECT OF THE REPORTED EVENT WAS EVALUATED AND SWELLING OF THE HOSE AT THE CRIMP COLLAR WAS OBSERVED. IN ADDITION, THE HOSE HAD A BEND AT THIS POINT AND EVIDENCED STRESS ON THE HOSE FITTING. THE BEND IN THE HOSE AND SEPARATION OF THE HOSE CRIMP WAS CAUSED BY THE SERVICE TECHNICIAN IMPROPERLY INSTALLING THE HOSE. STERIS CONSIDERS THE REPORTED EVENT TO BE ISOLATED.

    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 A WATER HOSE ON THEIR SYSTEM 1E SEPARATED ALLOWING WATER TO FLOW FROM THE UNIT. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351151 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1