BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 2000541 · Received February 24, 2011

    Report

    Report Number
    2084725-2011-00018
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE CUSTOMER WAS INFORMED THAT UNLESS THE STERRAD CYCLE COMPLETED, THE LOAD IS NOT CONSIDERED STERILE.THIS INCIDENT IS THE RESULT OF A USER ERROR.

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE SERVICE AND COMPLAINT HISTORY TRENDING STATEMENT. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 100S DID NOT REVEAL A TREND FOR STERILITY CLAIMS AND CYCLE CANCELLED.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE OCTOBER 10, 2002. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER. THE DHR (DEVICE HISTORY REVIEW) FOR THE STERRAD 100S SYSTEM CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 100S DID NOT REVEAL A TREND FOR HR OTHER. TRENDING ANALYSIS FOR HR OTHER ASSOCIATED TO THE STERRAD 100S FOUND THERE IS NOT A SIGNIFICANT TREND. THE CUSTOMER FAILED TO ACKNOWLEDGE THAT THE CYCLE WAS CANCELLED AND USED POTENTIAL NON STERILE ITEMS FROM A CANCELLED CYCLE ON PATIENTS. THE USER'S MANUAL OF THE STERRAD 100S STATES IN THE SECTION "CYCLE COMPLETION FLOW CHART": RED CANCELLATION MESSAGE SHOWS PARAMETERS WERE NOT MET. REJECT CYCLE AND RE- STERILIZE ALL ITEMS. THE USER'S MANUAL STATES IN THE SECTION "AUTOMATIC CANCELLATION": LOADS FROM CANCELED CYCLES SHOULD BE REPACKAGED, USING NEW POLYPROPYLENE WRAP AND TYVEK POUCHES, STERRAD CHEMICAL INDICATOR STRIPS, AND STERRAD SEALSURE CHEMICAL INDICATOR TAPE. IF A STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR WAS PLACED IN THE CANCELED LOAD, IT SHOULD BE DISCARDED AND A NEW BIOLOGICAL INDICATOR SHOULD BE PLACED IN THE CHAMBER BEFORE STARTING THE NEW CYCLE. THEREFORE, THIS ISSUE CAN BE ATTRIBUTED TO THE USER NOT CORRECTLY FOLLOWING THE USER'S GUIDE INSTRUCTIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEY DID NOT FOLLOW THEIR DEVICE PROCESSING PROCEDURES. AFTER A CANCELLED CYCLE, THE LOAD WAS INADVERTENTLY RELEASED AND PUT INTO USE AND ITEMS FROM THE UNPROCESSED LOAD WERE USED ON PATIENTS. THE FACILITY BECAME AWARE OF THE SITUATION WHEN A NURSE IN THE OPERATING ROOM OPENED ONE OF THE PACKAGES AND NOTED THE CHEMICAL INDICATOR INSIDE THE PACKAGE DID NOT CHANGE COLOR. THE CYCLE PRINT OUT WAS PULLED AND THE CANCELLATION OF THE CYCLE WAS NOTED ON THE PRINT OUT. A RECALL OF THE LOAD WAS INITIATED; HOWEVER, NOT ALL ITEMS WERE RECALLED. THERE ARE NO REPORTS OF HUMAN REACTION. TWO (B)(4) BATTERIES WERE USED IN A JOINT REVISION PROCEDURE. SIX OTHER (B)(4) BATTERIES AND ONE (B)(4) CAMERA WERE USED DURING PROCEDURES; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1