BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIS 20 STERILANT

    MDR report key: 1770579 · Received July 27, 2010

    Report

    Report Number
    3000251274-2010-00021
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 23, 2010
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K875280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE SYSTEM 1 PROCESSOR AND VERIFIED IT WAS OPERATING PROPERLY. THE PROCESSOR IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY FACILITY BIOMEDICAL PERSONNEL. THE UNIT REMAINS IN USE AND NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE EQUIPMENT. STERIS HAS DETERMINED THE CAUSE OF THIS EVENT TO BE USER ERROR. THE SYSTEM 1 OPERATOR MANUAL STATES ON PAGE 2-5: "ONCE THE ASPIRATOR PROBE IS INSERTED, DO NOT ATTEMPT TO REMOVE THE CONTAINER FROM THE STERILANT COMPARTMENT. IF IT IS NECESSARY TO REMOVE A CONTAINER WHICH HAS BEEN OPENED BUT NOT DILUTED, FOLLOW THE DISPOSAL INSTRUCTIONS FOR LEAKING/DAMAGED CONTAINERS". DISPOSAL INSTRUCTIONS STATE ON PAGE 2-7: "PUT ON PROTECTIVE ATTIRE TO INCLUDE WATERPROOF GLOVES, APRON, CHEMICAL GOGGLES OR FACE SHIELD. WEAR THE PROTECTIVE ATTIRE DURING THE ENTIRE PROCEDURE". ADDITIONALLY, THE SYSTEM 1 OPERATOR MANUAL INSTRUCTS USERS TO DISPOSE OF CUPS CONTAINING S20 CONCENTRATE BY: "REMOVE AN INDIVIDUAL BOX AND CONTAINER AND SUBMERGE IN A SINK FILLED WITH AT LEAST 12" (31 CM) INCHES OF WATER". THE USER FACILITY STAFF DID NOT SUBMERGE THE S20 CUP UNDER WATER BUT INSTEAD DOUBLE-BAGGED IT AND PLACED IT IN THE TRASH, RESULTING IN THE RELEASE OF STERILANT FUMES. FOLLOWING THIS EVENT, THE FACILITY ENVIRONMENTAL SERVICES STAFF RETRIEVED THE BAGS CONTAINING THE S20 CUP AND DISPOSED OF IT PROPERLY PER OPERATING INSTRUCTIONS. STERIS OFFERED THE USER FACILITY IN-SERVICE TRAINING ON THE PROPER USE AND DISPOSAL OF S20, HOWEVER THE FACILITY DECLINED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A CHEMICAL BURN AFTER LOADING A CUP OF STERIS 20 STERILANT (S20) INTO A SYSTEM 1 PROCESSOR. AFTER INSERTING AN S20 CUP INTO THE PROCESSOR THE EMPLOYEE THOUGHT SHE HAD NOT INSERTED THE ASPIRATOR PROPERLY AND PULLED THE PROBE OUT. HOWEVER, THE CUP HAD BEEN INSERTED PROPERLY AND WHEN THE EMPLOYEE PULLED THE ASPIRATOR PROBE OUT, THE S20 CUP LIFTED OUT ALONG WITH THE ASPIRATOR PROBE. AS A RESULT, S20 STERILANT SPILLED ONTO THE EMPLOYEE'S SHIRT AND ONTO HER ABDOMEN CAUSING A BURN. THE EMPLOYEE WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. SEVERAL EMPLOYEES IN THE IMMEDIATE AREA REPORTED THAT THEIR EYES BURNED DUE TO THE S20 ODORS; HOWEVER THESE EMPLOYEES DID NOT SEEK TREATMENT. THE S20 CUP WAS DISPOSED OF AND THE AFFECTED AREA WAS VENTILATED TO DISSIPATE THE ODORS. THE EMPLOYEE RECEIVING S20 STERILANT ON HER ABDOMEN FLUSHED THE AFFECTED AREA WITH WATER AND WENT TO THE EMPLOYEE HEALTH DEPARTMENT. THE EMPLOYEE DID NOT MISS ANY TIME FROM WORK AND THE FACILITY REPORTED SHE HAS NO SUSTAINING INJURIES. THE USER FACILITY WAS CONTACTED FOR TREATMENT INFORMATION; HOWEVER, THE FACILITY WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS 20 STERILANT STERIS 20 STERILANT MED STERIS CORPORATION - HOPKINS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other