BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1363316 · Received January 26, 2009

    Report

    Report Number
    2084725-2009-00032
    Event Type
    Malfunction
    Date Received
    January 26, 2009
    Date of Event
    December 19, 2008
    Report Date
    December 19, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MDR: 2084725-2009-00031.

    Description of Event or Problem · 1

    DURING AN IN-SERVICE REQUEST, AN ASP CLINICAL EDUCATION CLINICIAN (CEC) DISCOVERED THAT THE DISINFECT TIME SETTING ON TWO AER UNITS FOR CIDEX OPA WAS SET AT ONE MINUTE FOR BOTH UNITS. THE ASP CEC IMMEDIATELY STATED THAT THIS WAS THE INCORRECT AMOUNT OF TIME TO HIGH LEVEL DISINFECT AND THAT THE TIME NEEDED TO BE WAS A MINIMUM OF FIVE MINUTES. WHEN REVIEWING THE PRINTOUTS, A TOTAL DISINFECT TIME OF ONE MINUTE WAS IDENTIFIED. THE ASP CEC INFORMED THE NEW NURSE ADMINISTRATOR ABOUT THE INCORRECT SETTING FOR THE DISINFECT TIME TO BOTH AER UNITS. THE CUSTOMER REVIEWED THE DOCUMENTATION TO IDENTIFY HOW FAR BACK THE INCORRECT TIME HAD OCCURRED AND CONTACTED THE QUALITY DIVISION FOR THE SURGERY CENTER. THE ASP CEC REVIEWED THE PROPER USE OF THE AER UNITS WITH THE STAFF AND THE CORRECT PROCESSING TIME WAS ENTERED. THE STAFF WAS INSTRUCTED TO CHECK THE DISINFECT TIME PRIOR TO EACH ENDOSCOPE REPROCESSING. AT THIS TIME, THE CUSTOMER HAS NO INFORMATION ON THE NUMBER OF PATIENTS INVOLVED IN THE EVENT. THE CUSTOMER STATED THAT THE ISSUE IS STILL UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER AER EQUIPMENT NVE ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CIDEX OPA SOLUTION