BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS 40 STERILANT

    MDR report key: 2252047 · Received September 16, 2011

    Report

    Report Number
    3000251274-2011-00037
    Date Received
    September 16, 2011
    Date of Event
    August 16, 2011
    Report Date
    September 16, 2011
    Manufacturer
    STERIS CORPORATION-HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT, FOUND IT TO BE OPERATING PROPERLY, AND COULD NOT DUPLICATE THE REPORTED EVENT. THE USER FACILITY REPROCESSED THE SCOPES FROM THE CYCLE IN ANOTHER S1E PROCESSOR; THE FACILITY CONTINUED TO USE THE UNIT WITHOUT FURTHER ISSUE. THE OPERATOR SPLASHED RESIDUAL STERILANT ONTO HER ARMS DUE TO IMPROPER HANDLING OF THE STERIS 40 STERILANT CONCENTRATE CUP WHICH CONTAINED RESIDUAL STERILANT. THE OPERATOR WAS NOT WEARING PPE. PAGE 7-13 OF THE OPERATOR MANUAL CONTAINS THE FOLLOWING REGARDING HANDLING S40 CUPS AT THE END OF A PROCESSING CYCLE: "WARNING: ALWAYS VERIFY THAT THE STERILANT CONTAINER IS EMPTY AT THE COMPLETION OF THE CYCLE." AND "CAUTION: APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) IS REQUIRED WHEN HANDLING OR DISPOSING OF PARTIALLY FILLED, LEAKING, DAMAGED, OR EXPIRED CONTAINERS OF S40 STERILANT CONCENTRATE. MINIMALLY, PPE SHOULD CONSIST OF CHEMICAL-RESISTANT GLOVES, APRON, GOGGLES OR FACE SHIELD, AND ANY OTHER PROTECTION REQUIRED BY FACILITY PROCEDURES." THE CAUSE OF THE RESIDUAL STERILANT IS LIKELY DUE TO A KINKED ASPIRATOR PROBE. IF THE OPERATOR DOES NOT PROPERLY POSITION THE ASPIRATOR IN THE SYSTEM 1E PROCESSOR, THE ASPIRATOR PROBE CAN BECOME KINKED. A KINKED ASPIRATOR TUBE MAY CAUSE RESIDUAL STERILANT TO REMAIN IN THE STERIS 40 STERILANT CONCENTRATE CUP. PAGE 7-7 OF THE OPERATOR MANUAL ALERTS THE OPERATOR TO ENSURE THE ASPIRATOR TUBING IS NOT KINKED. STERIS OFFERED TO CONDUCT IN-SERVICE TRAINING HOWEVER THE USER FACILITY DECLINED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AFTER A PROCESSING CYCLE COMPLETED AN OPERATOR REMOVED THE USED STERIS 40 STERILANT CONCENTRATE CUP FROM THE PROCESSOR AND SPLASHED LIQUID ONTO HER FOREARMS. THE OPERATOR FLUSHED HER ARMS WITH WATER AND WENT TO THE EMERGENCY ROOM WHERE SHE WAS GIVEN ANTIBIOTIC OINTMENT. THE USER FACILITY REPORTED THAT HER CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS 40 STERILANT STERILANT MED STERIS CORPORATION-HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other