BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1

    MDR report key: 2024098 · Received March 18, 2011

    Report

    Report Number
    3000251274-2011-00010
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K875280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE SYSTEM 1 PROCESSOR AND FOUND THAT A HOSE CLAMP ON THE WATER INLET VALVE HAD NOT BEEN ADEQUATELY TIGHTENED DURING A PREVIOUS SERVICE REPAIR. THE TECHNICIAN TIGHTENED THE HOSE CLAMP, TESTED THE UNIT AND PLACED IT BACK INTO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED. THE STERIS SERVICE TECHNICIAN RECEIVED REFRESHER TRAINING ON THE PROPER INSTALLATION OF WATER INLET VALVES AND HOSE CLAMPS ON MARCH 17, 2011.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A STERILE CYCLE, THE SYSTEM 1 PROCESSOR LEAKED ONTO THE NEARBY FLOOR. THE SCOPES IN THE AFFECTED CYCLE WERE REPROCESSED BEFORE USE; NO INJURIES WERE REPORTED TO PATIENTS OR HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 LOW TEMPERATURE STERILIZER MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other