BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200, SINGLE DOOR

    MDR report key: 3211304 · Received July 8, 2013

    Report

    Report Number
    2084725-2013-00309
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 17, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-0998-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, HEALTH HAZARD EVALUATION, FAILURE MODE AND EFFECTS ANALYSIS AND CORRECTIVE ACTION AND PREVENTIVE ACTION. THE DHR (DEVICE HISTORY REVIEW) FOR STERRAD® 200 CART/RACK CANNOT BE PERFORMED SINCE INFORMATION REGARDING THE PRODUCT'S SERIAL NUMBER IS UNAVAILABLE. TRENDING ANALYSIS FOR "DAMAGED" ISSUES ASSOCIATED TO THE STERRAD® 200 FROM FEBRUARY, 2013 TO JANUARY, 2014 FOUND NO SIGNIFICANT TREND WAS OBSERVED. HHE (HEALTH HAZARD EVALUATION) WAS COMPLETED FOR THIS ISSUE. THE RISK WAS ASSESSED AS NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT INJURY FOR THE GENERAL POPULATION. FMEA (FAILURE MODE EFFECTS ANALYSIS) WAS REVIEWED. THE RPN FOR THIS FAILURE MODE IS GREATER THAN THE ACCEPTABLE LIMIT AND IS ADDRESSED THROUGH CAPA. CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) HAS BEEN INITIATED TO EVALUATE THE WELD ISSUE AND TO REDUCE THE ASSOCIATED RISK. IT WAS DETERMINED THAT INADEQUATE WELDING ON THE STERRAD® 200 CARRIAGE PUSH BAR MAY LEAD TO DISLODGEMENT AND SUBSEQUENT HUMAN INJURY DURING USE. THE ROOT CAUSE OF THE FAILURE OBSERVED HAS BEEN IDENTIFIED AS AN INADEQUATE MANUFACTURING WELD ON THE STERRAD® 200 CARRIAGE PUSH BAR. THE CUSTOMER COMPLAINT DAMAGE TO THE STERRAD® 200 CARRIAGE PUSH BAR HAS BEEN ATTRIBUTED TO A MANUFACTURING ISSUE. A CUSTOMER LETTER WAS SENT INFORMING STERRAD® 200 SYSTEM CARRIAGE OWNERS OF THIS ISSUE. NO FURTHER ACTION IS REQUIRED AT THIS TIME, HOWEVER THE ISSUE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEIR SYSTEM CARRIAGE PUSH BAR WAS 'BROKEN TO PIECES'. THE PUSH CART IS AN ACCESSORY TO THE STERRAD 200 STERILIZER FOR USE IN THE HEALTH CARE (HC) AND SCIENTIFIC AND INDUSTRIAL (S&I) ENVIRONMENTS. THERE WAS NO REPORTED MALFUNCTION OF THE STERRAD 200 STERILIZER GMP. AT THIS TIME, THERE IS NO REPORT OF ANY INJURY OR HARM. ASP WILL CONTINUE FOLLOW-UP EFFORTS. IN THE EVENT ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THIS MEDWATCH REPORT IS SUBMITTED AS A MALFUNCTION REPORT AFTER A SERIOUS INJURY TRIGGERING REPORT OF (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311412 STERRAD 200, SINGLE DOOR STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1