BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3053553 · Received April 11, 2013

    Report

    Report Number
    3000251274-2013-00037
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN WAS ONSITE AT THE USER FACILITY DURING THE TIME OF THE REPORTED EVENT. THE TECHNICIAN COMPLETED THE MAXPURE FILTER REPLACEMENT, RAN CYCLES AND RETURNED THE UNIT TO SERVICE. THE TECHNICIAN SHOWED THE EMPLOYEE SUBJECT OF THE REPORTED EVENT HOW TO PROPERLY REMOVE THE MAXPURE FILTER. THE OPERATOR MANUAL STATES (PP. 9-7), "REMOVE FILTER. PULL UP ON THE METAL RING ON THE TOP OF THE FILTER WHILE TWISTING TO REMOVE THE FILTER". THE USER FACILITY STATED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT IS NOT THE PRIMARY OPERATOR OF THE SYSTEM 1E.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC CYCLE THE SYSTEM 1E EXPERIENCED A MAXPURE FILTER FAULT. THE EMPLOYEE PROCEEDED TO CHANGE THE MAXPURE FILTER, UNSCREWED THE FILTER CAP AND BEGAN TO PULL THE FILTER OUT BY THE D-RING. THE D-RING BROKE LOOSE AND CUT HER RIGHT INDEX FINGER. A DOCTOR WAS IN THE AREA AND APPLIED A PRESSURE DRESSING ON THE EMPLOYEE'S FINGER. THE EMPLOYEE RETURNED TO WORK AND IS FINE WITH NO SUSTAINING INJURIES. NO PROCEDURAL DELAYS OR CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156337 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other