BEUDAMED
    FDA Adverse Event Summary report: N

    RAPICIDE GLUTERALDEHYDE

    MDR report key: 3830057 · Received May 23, 2014

    Report

    Report Number
    2150060-2014-00018
    Date Received
    May 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDIVATORS
    Product Code
    MED
    PMA / PMN Number
    K993042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS FIELD SERVICE ENGINEER (FSE) WENT TO FACILITY TO REPAIR THEIR ADVANTAGE PLUS AER AND DISCOVERED RAPICIDE GLUTARALDEHYDE WAS BEING USED AT ROOM TEMPERATURE MANUALLY SOAKING ENDOSCOPES DUE TO THEIR MACHINE BEING DOWN. RAPICIDE IS NOT APPROVED FOR ROOM TEMP MANUAL HIGH LEVEL DISINFECTION ACCORDING TO MEDIVATORS RAPICIDE IFU. THE FIELD SERVICE ENGINEER OBSERVED THAT THE RAPICIDE BOTTLE WERE LABELED (HAND WRITTEN) "USE AS CIDEX." THEY ARE REFERENCING CIDEX OPA MANUAL USE INSTRUCTIONS FOR HIGH LEVEL DISINFECTION INSTRUCTIONS. THE MEDIVATORS FSE INFORMED THE FACILITY THAT THEIR PROCEDURES OF MANUAL DISINFECTION USING THE RAPICIDE WERE INCORRECT. RAPICIDE REQUIRES HEAT TO REACH HIGH LEVEL DISINFECTION FOR ENDOSCOPES. THEREFORE, INADEQUATE AND INAPPRPRIATE REPROCESSING MAY CAUSE PATIENT INJURY VIA CROSS CONTAMINATION. THEIR MEDIVATORS ADVANTAGE PLUS MACHINE IS NOW OPERATING ACCORDING TO SPECIFICATIONS AFTER FSE REPAIRED THE MACHINE. IT WAS REPORTED THE MACHINE WAS DOWN AND THE FACILITY WAS MANUAL REPROCESSING SCOPES FOR 2 DAYS. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN MEDIVATORS COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THE CASE STATES THAT A FACILITY WAS USING RAPICIDE GLUTARALDEHYDE FOR MANUAL CLEANING OF THEIR ENDOSCOPES WHILE THEIR MEDIVATORS ADVANTAGE PLUS MACHINE WAS BEING REPAIRED. MEDIVATORS RAPICIDE IS NOT APPROVED FOR ROOM TEMP MANUAL HLD AS THIS PRODUCT REQUIRES HEAT. REPORTED THE MACHINE HAD BEEN DOWN FOR TWO DAYS. POTENTIAL CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308751 RAPICIDE GLUTERALDEHYDE HIGH LEVEL DISINFECTANT MED MEDIVATORS ML02-0059

    Patients

    Seq Age Sex Outcome Treatment
    1