BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1032046 · Received April 21, 2008

    Report

    Report Number
    1527821-2008-00007
    Event Type
    Other
    Date Received
    April 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 21, 2008
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE FACILITY LAB DIRECTOR, FOUR OF THE FIVE INDIVIDUALS REPORTED EYE IRRITATION BUT NEVER SOUGHT MEDICAL TREATMENT. THE OTHER INDIVIDUAL, WHO HAS A HISTORY OF ASTHMA, WAS TREATED IN THE ER WITH A NEBULIZER FOR BREATHING DIFFICULTY. HE RETURNED TO WORK THE NEXT DAY. HE FOLLOWED-UP WITH HIS PERSONAL PHYSICIAN BUT HAS REQUIRED NO FURTHER MEDICAL TREATMENT. THE LAB DIRECTOR WAS UNCERTAIN AS TO WHETHER APPROPRIATE VENTILATION WAS PROVIDED TO THE ROOM DURING THE EVENT. PRIOR TO THE INCIDENT, ALL FIVE EMPLOYEES HAD REC'D TRAINING ON THE APPROPRIATE PROCEDURES AND PRECAUTIONS FOR DISPOSING OF S20. THOSE INCLUDE INCREASING THE VENTILATION TO THE ROOM, WEARING PPE, AND SUBMERSING ALL EFFECTED S20 CONTAINERS IN WATER. BECAUSE THESE INSTRUCTIONS WERE NOT FOLLOWED IN THIS CASE, STERIS HAS RECOMMENDED ADD'L IN-SERVICE TRAINING AT THE HOSPITAL.

    Description of Event or Problem · 1

    STERIS WAS ADVISED BY A FACILITY, EMERGENCY SERVICE SPECIALIST THAT FIVE INDIVIDUALS AT COMPANY INHALED FUMES FROM STERIS 20 STERILANT CONCENTRATE (S20). IT WAS REPORTED THAT FIVE OR SIX CONTAINERS OF S20 ARRIVED DAMAGED AND THAT THE FACILITY HAD FAILED TO IMMERSE ALL BUT ONE OF THE DAMAGED CONTAINERS IN WATER AS DIRECTED BY STERIS'S INSTRUCTIONS FOR USE AND THE MSDS PROVIDED WITH THE STERILANT. IT WAS INITIALLY REPORTED THAT NONE OF THE INDIVIDUALS WAS HURT OR REPORTED ANY ILL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 LOW TEMPERATURE STERILIZERS MLR STERIS CORPORATION 4544721 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other