BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 5069289 · Received September 10, 2015

    Report

    Report Number
    2084725-2015-00331
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 13, 2015
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED STERILIZATION PRODUCTS (ASP) RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER STATING THE LOAD INVOLVED WITH THE LOW PRESSURE IN INJECTION ERROR WAS REPROCESSED. AS A RESULT, THIS COMPLAINT IS DEEMED NOT REPORTABLE FOR UNKNOWN LOAD STATUS.

    Additional Manufacturer Narrative · 1

    (B)(4). LOAD NOT RECALLED.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED A LOW PRESSURE IN INJECTION WITH THEIR STERRAD 100S AND IT IS UNKNOWN IF THE LOAD WAS REPROCESSED PRIOR TO BEING RELEASED FOR USE ON A PATIENT(S). 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 OR HIGH LEVEL DISINFECTION. 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
    598597 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 0101963265

    Patients

    Seq Age Sex Outcome Treatment
    1