BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1651996 · Received April 6, 2010

    Report

    Report Number
    3000251274-2010-00010
    Event Type
    Injury
    Date Received
    April 6, 2010
    Date of Event
    March 3, 2010
    Report Date
    April 6, 2010
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K875280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE SYSTEM 1 PROCESSOR AND FOUND THE UNIT'S PROCESSING TRAY TO BE FULL OF WATER. THE TECHNICIAN EMPTIED AND CLEANED THE TRAY AND RAN FOUR TEST CYCLES; ALL CYCLES EXHIBITED PASSING RESULTS AND NO ISSUES WERE NOTED WITH THE PROCESSOR LID. AN ADDITIONAL INSPECTION OF THE LID LATCH AND LID ASSEMBLY FOUND THAT THE LID WAS CORRECTLY POSITIONED. AS A PRECAUTION, THE TECHNICIAN REPLACED THE LID LATCH AND LID ASSEMBLY. THE PROCESSOR HAS REMAINED IN USE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED WITH THE EQUIPMENT. THE HOSPITAL HAS BEEN REMINDED SEVERAL TIMES THAT THE SYSTEM 1 OPERATOR MANUAL REQUIRES THE PROCESSING TRAY AND CHAMBER TO BE CLEANED DAILY WITH A "SOFT CLOTH DAMPENED WITH 70% ISOPROPYL ALCOHOL". NOT FOLLOWING THE DEVICES INDICATIONS FOR USE MAY HAVE CAUSED STRESS ON THE LATCHING MECHANISM, RESULTING IN THE PREMATURE OPENING OF THE LID. REFRESHER IN-SERVICE TRAINING FOR THE HOSPITAL REGARDING PROPER USE OF SYSTEM 1 HAS BEEN OFFERED ON SIX DIFFERENT OCCASIONS, HOWEVER THE HOSPITAL HAS NOT RESPONDED TO STERIS' ATTEMPTS TO SCHEDULE THE TRAINING.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A SYSTEM 1 PROCESSOR LID OPENED DURING A PROCESSING CYCLE AND S20 STERILANT SPLASHED ONTO A NEARBY HOSPITAL EMPLOYEE. THE EMPLOYEE WAS TREATED WITH BURN DRESSINGS AT THE MINOR INJURIES DEPARTMENT FOR SMALL BLISTERS ON HER LOWER LEGS. THE EMPLOYEE MISSED NO TIME FROM WORK AND REPORTS THAT HER BLISTERS HAVE HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 STERIS SYSTEM 1 MED STERIS CORPORATION - HOPKINS P1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other