BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSD-102

    MDR report key: 7119147 · Received December 14, 2017

    Report

    Report Number
    2150060-2017-00053
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 14, 2017
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FEB
    UDI-DI
    00677964035647
    PMA / PMN Number
    K914145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS CLINICAL EDUCATION SPECIALIST WAS AT THE FACILITY PERFORMING AN IN SERVICE WHEN HE NOTICED THE FACILITY WAS USING RAPICIDE GLUTARALDEHYDE HIGH LEVEL DISINFECTANT WITH THEIR SSD-102 AUTOMATED ENDOSCOPE REPROCESSOR. THE FACILITY USUALLY REPROCESSES ENDOSCOPES USING RAPICIDE OPA HIGH LEVEL DISINFECTANT. RAPICIDE GLUTARALDEHYDE AND RAPICIDE OPA REQUIRE DIFFERENT TEST STRIPS AND SETTINGS. THE FACILITY CONTINUED TO USE RAPICIDE OPA TEST STRIPS AND SETTINGS WHILE REPROCESSING WITH RAPICIDE GLUTARALDEHYDE HLD FOR A DAY AND A HALF. IN ACCORDANCE WITH THE SSD-102 AER INSTRUCTIONS FOR USE, THE EFFICACY OF THE DISINFECTANT MUST BE MONITORED DAILY USING THE CORRECT TEST STRIPS. IF THE POTENCY IS BELOW THE MINIMUM RECOMMENDED CONCENTRATION, THE CHEMISTRY SHOULD BE DISCARDED AND REPLACED WITH FRESH SOLUTION. USING THE INCORRECT TEST STRIPS WOULD NOT HAVE INDICATED THE CORRECT MRC PER THE CHEMISTRY USED. ADDITIONALLY, THE IFU STATES THE USER SHOULD VERIFY THE SETTINGS ARE APPROPRIATE FOR THE DISINFECTANT USED. THUS, THE FACILITY WAS NOT REPROCESSING ENDOSCOPES IN ACCORDANCE WITH THE AER'S IFU AND THERE IS POTENTIAL HIGH LEVEL DISINFECTION OF THE ENDOSCOPES WAS NOT REACHED. MEDIVATORS CLINICAL EDUCATION SPECIALIST INFORMED THE FACILITY THAT THE CHEMISTRY USED WAS INCORRECT WHILE USING THE RAPICIDE OPA TEST STRIPS AND SETTINGS. THE FACILITY WILL BEGIN TO ORDER RAPICIDE OPA HLD AGAIN. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    MEDIVATORS CLINICAL EDUCATION SPECIALIST WAS AT THE FACILITY PERFORMING AN IN SERVICE WHEN HE NOTICED THE FACILITY WAS USING RAPICIDE GLUTARALDEHYDE HIGH LEVEL DISINFECTANT WITH THEIR SSD-102 AUTOMATED ENDOSCOPE REPROCESSOR. THE FACILITY USUALLY REPROCESSES ENDOSCOPES USING RAPICIDE OPA HIGH LEVEL DISINFECTANT. RAPICIDE GLUTARALDEHYDE AND RAPICIDE OPA REQUIRE DIFFERENT TEST STRIPS AND AER SETTINGS. THE FACILITY CONTINUED TO USE RAPICIDE OPA TEST STRIPS AND SETTINGS WITH RAPICIDE GLUTARALDEHYDE HLD. THE FACILITY WAS NOT REPROCESSING ENDOSCOPES IN ACCORDANCE WITH THE AER'S IFU AND THERE IS POTENTIAL HIGH LEVEL DISINFECTION OF THE ENDOSCOPES WAS NOT REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898210 SSD-102 AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS INC. 00677964035647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other