BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1558289 · Received December 8, 2009

    Report

    Report Number
    MW5013875
    Event Type
    Injury
    Date Received
    December 8, 2009
    Date of Event
    August 7, 2009
    Report Date
    December 8, 2009
    Manufacturer
    *
    Product Code
    FLF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO RESPIRATORY THERAPISTS WERE CLEANING AN OLYMPUS BRONCHOSCOPE USING THE STERIS SYSTEM 1 PRODUCT. THE MACHINE INDICATED ON THE DISPLAY PANEL, THAT IT HAD COMPLETED CLEANING THE INSTRUMENT. RT# 1 OPENED THE DOOR TO THE DEVICE AND WAS IMMEDIATELY EXPOSED WITH CAUSTIC VAPORS TO THE FACE. RT #2 STANDING BEHIND RT #1 AT THE DEVICE, WAS ALSO EXPOSED TO THE VAPOR FUMES AND WENT INTO AN ASTHMATIC ATTACK REQUIRING EMERGENT MEDICAL ATTENTION TO ALLEVIATE THE BRONCHOCONSTRICTION AND WAS SUBSEQUENTLY SENT HOME FROM WORK AND MISSED WORK DAYS DUE TO EXPOSURE. RT# 1 WAS EVALUATED FOR CHEMICAL INJURY TO THE EYES AND FACE AND REC'D MEDICAL ATTENTION FOR CHEMICAL EXPOSURE. FOLLOWING THE MEDICAL EVAL, RT# 1 ALSO MISSED WORK TIME DUE TO INCIDENT EXPOSURE AND THE ASSOCIATED EFFECTS. THE SYS WAS LOCKED AND TAGGED OUT OF SERVICE. COMPANY'S ACCOUNT MANAGER WAS CONTACTED AND CAME TO THE FACILITY IN 2009 TO ATTEND A MEETING RELATED TO THE EVENT. DATES OF USE: 2000 - 2009.

    Description of Event or Problem · 2

    TWO RESPIRATORY THERAPISTS WERE CLEANING AN OLYMPUS BRONCHOSCOPE USING THE STERIS SYSTEM 1 PRODUCT. THE MACHINE INDICATED ON THE DISPLAY PANEL, THAT IT HAD COMPLETED CLEANING THE INSTRUMENT. RT# 1 OPENED THE DOOR TO THE DEVICE AND WAS IMMEDIATELY EXPOSED WITH CAUSTIC VAPORS TO THE FACE. RT #2 STANDING BEHIND RT #1 AT THE DEVICE, WAS ALSO EXPOSED TO THE VAPOR FUMES AND WENT INTO AN ASTHMATIC ATTACK REQUIRING EMERGENT MEDICAL ATTENTION TO ALLEVIATE THE BRONCHOCONSTRICTION AND WAS SUBSEQUENTLY SENT HOME FROM WORK AND MISSED WORK DAYS DUE TO EXPOSURE. RT# 1 WAS EVALUATED FOR CHEMICAL INJURY TO THE EYES AND FACE AND REC'D MEDICAL ATTENTION FOR CHEMICAL EXPOSURE. FOLLOWING THE MEDICAL EVAL, RT# 1 ALSO MISSED WORK TIME DUE TO INCIDENT EXPOSURE AND THE ASSOCIATED EFFECTS. THE SYS WAS LOCKED AND TAGGED OUT OF SERVICE. COMPANY'S ACCOUNT MANAGER WAS CONTACTED AND CAME TO THE FACILITY IN 2009 TO ATTEND A MEETING RELATED TO THE EVENT. DATES OF USE: 2000 - 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 STERIS FLF * 90A2

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| S
    2 Other| S