BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA

    MDR report key: 11606655 · Received April 1, 2021

    Report

    Report Number
    2028492-2021-00004
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 3, 2021
    Report Date
    August 2, 2021
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    PMA / PMN Number
    510K EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE. ISSUE WAS RESOLVED BY REPLACING THE WASTE VALVES. THE REPLACED PARTS WERE NOT AVAILABLE FOR INVESTIGATION SINCE THEY WERE DISPOSED. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE THE ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION. (B)(6). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THAT DURING DECONTAMINATION, BOTH WASTE BOTTLES OF THEIR BENCHMARK ULTRA INSTRUMENT WERE FILLING UP. WASTE FLUID CONTINUED TO FLOW ON WASTE BOTTLE ONE WHEN THE WASTE CONTAINER CARBOY WAS REMOVED EVEN THOUGH THE WASTE WAS DRAINING IN WASTE BOTTLE TWO AS INDICATED BY THE SOFTWARE. SPILL WAS CONTAINED, NO INJURY TO PERSONNEL, NO PATIENT WAS AFFECTED. THE ISSUE WAS RESOLVED BY REPLACING THE WASTE VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501499 BENCHMARK ULTRA SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1