BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3589891 · Received January 23, 2014

    Report

    Report Number
    3000251274-2014-00006
    Date Received
    January 23, 2014
    Date of Event
    December 27, 2013
    Report Date
    January 23, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE FACILITY EMPLOYEE WHO REPORTED THE EVENT CONTACTED STERIS REGARDING HER REACTION TO THE ODOR OF S40 STERILANT. A STERIS REPRESENTATIVE CONTACTED THE EMPLOYEE ON (B)(4) 2014 TO DISCUSS HER CONCERNS. THE EMPLOYEE STATED SHE SOUGHT MEDICAL TREATMENT BUT THAT HER PHYSICIAN TOLD HER THAT SHE IS FINE. STERIS OFFERED TO PROVIDE HER WITH THE MSDS, OPERATOR INSTRUCTIONS, AND INSTRUCTION FOR USE FOR S40 STERILANT, BUT THE EMPLOYEE DECLINED BECAUSE SHE ALREADY HAD THE DOCUMENTATION. STERIS OFFERED ITS ONGOING SUPPORT AND AVAILABILITY TO THE EMPLOYEE AS NEEDED. DURING STERIS'S DISCUSSION WITH THE EMPLOYEE, SHE CONFIRMED THAT SHE HAS BEEN WORKING IN THE AREA IN WHICH THE SYSTEM 1E IS LOCATED FOR A YEAR BUT IS NOT AN OPERATOR OF THE SYSTEM 1E AND DOES NOT HANDLE S40 STERILANT. FOLLOWING THE REPORTED EVENT, A NEW VENTILATION SYSTEM WAS INSTALLED OVER THE SYSTEM 1E UNIT. STERIS IS RESPONSIBLE FOR MAINTAINING THE SYSTEM 1E UNIT PURSUANT TO A SERVICE CONTRACT WITH THE FACILITY. A REVIEW OF SERVICE RECORDS REVEALS NO ISSUES HAVE BEEN REPORTED WITH THE UNIT SINCE THE INCIDENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE SMELL FROM S40 STERILANT USED IN THE SYSTEM 1E IS BOTHERING AN EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53576 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other