BEUDAMED
    FDA Adverse Event Summary report: N

    16" CENTURY STERILIZER

    MDR report key: 3083150 · Received April 29, 2013

    Report

    Report Number
    3005899764-2013-00039
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE AND FOUND THAT AN OPERATOR WAS COMPLETING FLUSH PROCEDURES JUST BEFORE MIDNIGHT AND SET OFF THE FIRE PROTECTION SYSTEM AS THE UNIT RELEASED STEAM. THE OPERATOR DID NOT TAKE FURTHER ACTION AND POWERED DOWN THE UNIT FOR THE NIGHT. WHEN THE UNIT WAS POWERED ON THE NEXT MORNING IT WAS OPERATING NORMALLY; NO ISSUES WERE NOTED. THE CUSTOMER WAS UNABLE TO DUPLICATE THE EVENT OR IDENTIFY WHERE THE STEAM WAS COMING FROM BUT REPORTED VISIBLE STEAM ACROSS THE CEILING OF THE MECHANICAL ROOM. THE TECHNICIAN INSPECTED THE CENTURY STERILIZER AND FOUND THE ALARM "TOO LONG IN CHARGE" DISPLAYED, INDICATING THE STEAM GENERATOR WAS NOT POWERING ON AT THE PROPER TIME. FURTHER INVESTIGATION OF THE STERILIZER REVEALED THE DRAIN VALVE WAS NOT CLOSING PROPERLY; THE VALVE WAS 'STIFF' AND DIFFICULT TO CLOSE. THE TECHNICIAN CLEANED AND APPLIED GREASE TO THE DRAIN VALVE AND STEM. THE TECHNICIAN CONFIRMED THE DRAIN VALVE WAS FUNCTIONING TO SPECIFICATION, RAN A TEST CYCLE AND CONFIRMED THE UNIT OPERATIONAL. THE TECHNICIAN THEN INSPECTED THE STEAM GENERATOR AND FOUND THE TIMER CONTROL WAS NOT UPDATED TO DAYLIGHT SAVINGS TIME. AS A RESULT, THE STEAM GENERATOR WAS POWERING ON ONE (1) HOUR LATER, CAUSING THE STERILIZER TO REMAIN IN THE HEAT UP INITIATION PHASE FOR TOO LONG. THE TECHNICIAN MANUALLY ADJUSTED THE TIME ON THE STEAM GENERATOR. THE TECHNICIAN INSPECTED THE SAFETY VALVE AND AUTO DRAIN OF THE STEAM GENERATOR AND FOUND NO EVIDENCE OF STEAM OUTPUT. THE PRESSURE CONTROL POINTS WERE ADJUSTED TO 65-75 PSI AS A PRECAUTIONARY MEASURE. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT OR DETERMINE THE DISCHARGE POINTS OF THE STEAM. THE TECHNICIAN RAN A TEST CYCLE, CONFIRMED THE UNIT OPERATIONAL AND RETURNED IT TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR 16" CENTURY STERILIZER WAS RELEASING STEAM AND SET OFF THE FIRE ALARM WITHIN THEIR FACILITY. THE FIRE DEPARTMENT RESPONDED. NO EVACUATIONS OCCURRED. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED. NO INJURIES TO HOSPITAL STAFF OR PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183878 16" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1