BEUDAMED
    FDA Adverse Event Summary report: N

    RAPICIDE HIGH LEVEL DISINFECTANT AND STERILANT

    MDR report key: 3832259 · Received November 18, 2013

    Report

    Report Number
    2150060-2013-00014
    Date Received
    November 18, 2013
    Date of Event
    October 17, 2013
    Report Date
    October 13, 2013
    Manufacturer
    MEDIVATORS
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION AND DEVICE EVALUATION, THE CAUSE OF THE CHEMICAL EXPOSURE IS UNCERTAIN. CHEMICAL COLITIS CASES HAVE NOT BEEN FORMALLY CONFIRMED AND REPORTED TO THE MANUFACTURER. MEDIVATORS HAS ATTEMPTED TO CONTACT THE FACILITY AND TO DATE HAS RECEIVED NO RESPONSE FROM THESE ATTEMPTS. DUE TO THE UNCERTAINTY OF THESE CLAIMS, MEDIVATORS DECIDED TO SUBMIT AN MDR TO REPORT THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, MEDIVATORS WILL REVIEW AND DETERMINE IF FURTHER INVESTIGATION AND/OR A SUPPLEMENTAL REPORT IS NECESSARY. LIMITED INFORMATION CONCERNING THE PATIENT STATUS OF THIS POTENTIAL CHEMICAL COLITIS CASE IS AVAILABLE FROM THE USE FACILITY. ADDITIONAL DETAILS TO HELP DETERMINE THE ROOT CAUSE HAVE NOT BEEN REPORTED TO MEDIVATORS AS OF YET. MEDIVATORS DISPATCHED A FIELD SERVICE ENGINEER AND A PERFORMANCE TEST WERE COMPLETED ON THE UNIT. THE FSE REVIEWED MACHINE OPERATIONS WITH OPERATORS AND BIOMED. THEY ALSO DISCUSSED CONCERNS AND ISSUES THE FACILITY MIGHT BE HAVING WITH THE MACHINES. THE FSE DOUBLE CHECKED RINSE CYCLE SETTINGS BY PERFORMING TWO TEST CYCLES. THE OBSERVATION OF THIS TEST DETERMINED THAT THE UNIT IS PERFORMING CORRECTLY TO SPECIFICATIONS. THE FSE REPORTED TO RECOMMENDING A PM SERVICE. NOTE: MANUFACTURING DATE IS JULY 31, 2002. THESE MACHINES ARE OLD. IT IS RECOMMENDED BY MEDIVATORS TO HAVE A PM DONE EVERY YEAR AND RECORDS SHOW THAT THIS FACILITY HASN'T RECEIVED SERVICE FROM A TRAINED MEDIVATORS FSE SINCE 2009. LAST DOCUMENTED PM WAS IN 2008 AND THAT WAS DONE BY OLYMPUS NOT MEDIVATORS. MEDIVATORS SUSPECTS THE ROOT CAUSE POTENTIALLY TO BE PATIENT SENSITIVITY TO THE RAPICIDE CHEMICAL OR IT POTENTIALLY COULD BE USER ERROR. USER ERROR COULD DERIVE FROM A NUMBER OF POSSIBILITIES SUCH AS IMPROPER HOOK-UP USED FOR THE SCOPE, IMPROPER MACHINE MAINTENANCE, ETC.

    Description of Event or Problem · 1

    USER FACILITY REPORTED ONE CASE OF CHEMICAL COLITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596974 RAPICIDE HIGH LEVEL DISINFECTANT AND STERILANT GLUTARAIDEHYDE MED MEDIVATORS ML02-0059

    Patients

    Seq Age Sex Outcome Treatment
    1 DSD-201