BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIVATOR DSD EDGE DUAL BASIN AER

    MDR report key: 4117431 · Received September 19, 2014

    Report

    Report Number
    MW5038335
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDIVATORS INC
    Product Code
    KOG
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HIGH LEVEL DISINFECTANT METRICIDE OPA PLUS WAS USED AS A BACKUP DISINFECTANT FOR THE MEDIVATORS DSD EDGE DUAL BASIN AER (AUTOMATED ENDOSCOPE PREPROCESSOR) WHICH IS ONLY DESIGNED TO USE RAPICIDE PA HIGH LEVEL DISINFECTANT PART A/PART B. OPA PLUS IS AN FDA APPROVED HIGH LEVEL DISINFECTANT (B)(4). THIS CHEMICAL CAN BE REUSED FOR UP TO 14 DAYS. WE DID NOT REUSE THIS CHEMICAL. THE AER PROCESS AT THE FACILITY RUNS 25 MINUTES AT 35 DEGREES CELSIUS. (B)(4). RAPICIDE PA: IS A SINGLE USE, PERACETIC ACID BASED SOLUTION, FDA APPROVED HIGH LEVEL DISINFECTANT THAT REQUIRES NO NEUTRALIZATION AND IS DESIGNED FOR USE IN MEDIVATORS DSD EDGE AER. (B)(4). CORRECTIVE ACTION HAS BEEN TAKEN TO ONLY USE RAPICIDE PA IN THE AER, PER MFR'S INSTRUCTIONS. TO DATE, THERE HAVE BEEN NO REPORTS OF PT INJURY OR ILLNESS AS A RESULT OF OUR PRIOR PROTOCOL. INFECTION RATE RELATED TO GI CASES PRIOR TO METRICIDE OPA PLUS USAGE: 0.05%. PRESENT INFECTION RATE RELATED TO GI CASES: 0%. WE WILL CONTINUE TO MONITOR OUR DATA FOR ANY CHANGES. DATES OR USE: (B)(6) 2013-(B)(6) 2014 (ESTIMATE) (B)(6) 2014-PRESENT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583181 MEDIVATOR DSD EDGE DUAL BASIN AER AUTOMATED ENDOSCOPE REPROCESSOR KOG MEDIVATORS INC DSD EDGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention