BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSD-201

    MDR report key: 8579728 · Received May 3, 2019

    Report

    Report Number
    2150060-2019-00039
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 3, 2019
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FEB
    UDI-DI
    00677964035647
    PMA / PMN Number
    K914145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A FACILITY REPORTED ATTEMPTING TO LOAD THE INCORRECT CHEMISTRY, RAPICIDE PA HIGH LEVEL DISINFECTANT (HLD), IN THEIR SSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). ADDITIONALLY, THE SCOPE TECHNICIAN LOADING THE CHEMISTRY WAS EXPOSED TO RAPICIDE PA HLD ON THE RIGHT HAND AND LEFT ARM. RAPICIDE PA IS NOT FOR USE WITH THE SSD-201 AER, THEREFORE, THE FACILITY WAS NOT USING THEIR AER IN ACCORDANCE WITH THE AER INSTRUCTIONS FOR USE. THUS, THERE IS POTENTIAL THAT ENDOSCOPES REPROCESSED IN THE AER WERE NOT APPROPRIATELY HIGH-LEVEL DISINFECTED AND, THEREFORE, POTENTIAL FOR PATIENT CROSS-CONTAMINATION. RAPICIDE PA PART A AND PART B WAS REPORTEDLY BEING MIXED BY THE USER IN THE RESERVOIR TANK OF THE SSD-201 AER. RAPICIDE PA IS A SINGLE SHOT CHEMISTRY THAT IS DOSED BY THE AER. THE SSD-201 USES A REUSABLE CHEMISTRY, THUS, THIS IS OFF-LABEL USE AND USER NEGLIGENCE OF THE INSTRUCTIONS FOR USE OF BOTH THE CHEMISTRY AND AER. MEDIVATORS TECHNICAL SERVICES INSTRUCTED THE FACILITY TO REMOVE THE RAPICIDE PA FROM THE SSD-201. MEDIVATORS REGULATORY ATTEMPTED TO FOLLOW UP WITH THE FACILITY FOR ADDITIONAL INFORMATION WITH NO SUCCESS. THE FACILITY DID NOT SPECIFY IF ANY ENDOSCOPES WERE REPROCESSED USING THE INCORRECT HLD. IT IS UNKNOWN IF ANY MEDICAL ATTENTION WAS SOUGHT AND IF THERE WERE ANY LASTING EFFECTS OF THE SKIN EXPOSURE. ADDITIONALLY, IT IS UNKNOWN IF THE EMPLOYEE WAS WEARING PROPER PPE (I.E. GLOVES) WHEN HANDLING THE HLD AS INSTRUCTED PER THE PRODUCT LABELING. THERE HAVE BEEN NO REPORTS OF PATIENT HARM. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    A FACILITY REPORTED ATTEMPTING TO LOAD AN INCORRECT CHEMISTRY, RAPICIDE PA HIGH LEVEL DISINFECTANT (HLD), IN THEIR SSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). ADDITIONALLY, THE SCOPE TECHNICIAN LOADING THE CHEMISTRY WAS EXPOSED TO RAPICIDE PA HLD ON THE RIGHT HAND AND LEFT ARM. RAPICIDE PA IS NOT FOR USE WITH THE SSD-201 AER, THEREFORE, THE FACILITY WAS NOT USING THEIR AER IN ACCORDANCE WITH THE AER INSTRUCTIONS FOR USE. THUS, THERE IS POTENTIAL THAT ENDOSCOPES REPROCESSED IN THE AER WERE NOT APPROPRIATELY HIGH-LEVEL DISINFECTED AND, THEREFORE, POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373289 SSD-201 AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS INC. 00677964035647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other