BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 5095550 · Received September 22, 2015

    Report

    Report Number
    2084725-2015-00383
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 24, 2015
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED STERILIZATION PRODUCTS (ASP) RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER STATING THERE WAS NO LOAD INVOLVED WITH THE CHAMBER PLASTICS ISSUE. AS A RESULT, THIS COMPLAINT IS DEEMED NOT REPORTABLE FOR UNKNOWN LOAD STATUS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DAMAGED CHAMBER PLASTIC PARTS WITH THEIR STERRAD® 100S AND IT IS UNKNOWN IF THE LOAD WAS REPROCESSED PRIOR TO BEING RELEASED FOR USE ON A PATIENT(S). THIS EVENT IS BEING REPORTED AS THE LOAD STATUS IS UNKNOWN. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED THAT THIS SITUATION PRESENTS A POTENTIAL RISK OF INFECTION. ASP RECOGNIZES THAT IN MANY CASES IT WOULD BE DIFFICULT TO TRACE INFECTION BACK TO THE STERILIZATION. AS A MATTER OF POLICY ASP HAS THEREFORE DECIDED TO REPORT CASES OF CANCELLED CYCLES IF THE COMPLAINANT DOES NOT CONFIRM THAT THE LOAD WAS REPROCESSED PRIOR TO USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626151 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 105248

    Patients

    Seq Age Sex Outcome Treatment
    1