BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER-2 OPTIMA

    MDR report key: 6934997 · Received October 10, 2017

    Report

    Report Number
    2150060-2017-00044
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 13, 2017
    Report Date
    October 10, 2017
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    NVE
    UDI-DI
    00677964052491
    PMA / PMN Number
    K871712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTEDLY OBSERVED THAT THE METRICIDE OPA PLUS HIGH LEVEL DISINFECTANT USED IN THEIR CER-2 OPTIMA AUTOMATED ENDOSCOPE REPROCESSOR HLD RESERVOIR WAS CLOUDY IN APPEARANCE. THE FACILITY CONFIRMED THAT THE OPA SOLUTION WAS NOT EXPIRED AND THE MINIMUM REQUIRED CONCENTRATION (MRC) PASSED FOR THE REPROCESSING CYCLE. THE INITIAL REPORTER THOUGHT SOMEONE MAY HAVE ACCIDENTALLY TOPPED OFF THE DISINFECTANT RESERVOIR WITH METRIZYME DETERGENT, WHICH THEY USE AS PART OF THEIR PRE-CLEANING STEP PRIOR TO HIGH-LEVEL DISINFECTING SCOPES. THEREFORE, IT IS UNKNOWN IF SCOPES WERE PROPERLY HIGH-LEVEL DISINFECTED. IT IS ALSO UNKNOWN IF SCOPES WERE USED ON PATIENTS, THUS POTENTIAL RISK OF PATIENT ADVERSE EFFECTS FROM IMPROPER HLD OF SCOPES. MEDIVATORS TECHNICAL SERVICES ADVISED THE CUSTOMER TO DUMP THE DISINFECTANT FROM THE RESERVOIR, RINSE THOROUGHLY WITH WATER, THEN REFILL WITH THE OPA SOLUTION AND TEST THE MRC USING THE SOLUTION TEST STRIPS. THE CUSTOMER FOLLOWED THESE DIRECTIONS AND CONFIRMED THAT THE MRC PASSED. TO DATE, THERE HAVE BEEN NO REPORTS OF PATIENT HARM. MEDIVATORS WILL CONTINUE MONITORING THIS COMPLAINT IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    A FACILITY REPORTED NOTICING THE METRICIDE OPA PLUS HIGH LEVEL DISINFECTANT USED IN THEIR CER 2 OPTIMA AUTOMATED ENDOSCOPE REPROCESSOR HLD RESERVOIR WAS CLOUDY IN APPEARANCE. IT WAS SUSPECTED THAT SOMEONE ACCIDENTALLY TOPPED OFF THE DISINFECTANT RESERVOIR WITH METRIZYME DETERGENT. THERE IS POTENTIAL FOR PATIENT ADVERSE EFFECTS SUCH AS CROSS CONTAMINATION IF SCOPES ARE NOT PROPERLY HIGH LEVEL DISINFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715653 CER-2 OPTIMA AUTOMATED ENDOSCOPE REPROCESSOR NVE MEDIVATORS, INC. 00677964052491

    Patients

    Seq Age Sex Outcome Treatment
    1 Other