BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA STAINER MODULE

    MDR report key: 2880524 · Received December 19, 2012

    Report

    Report Number
    2028492-2012-00009
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN RETURNED FROM THE CUSTOMER SITE AND IS BEING EXAMINED IN DETAIL. AS OF THE DATE OF THIS REPORT AT LEAST ONE ROOT CAUSE OF THE SHORT CIRCUIT EVENT HAS BEEN DETERMINED TO BE A LEAK AROUND A PLUG IN THE BASE OF A RESERVOIR THAT CONTAINS ONE OF THE AQUEOUS BULK FLUIDS USED IN THE STAINING PROCESS. THIS BULK SOLUTION (BUFFER) IS HIGH IN SALT CONTENT RESULTING IN A CONDUCTIVE BRIDGE OF DEPOSITED SOLIDS TO FORM ACROSS ELECTRICAL COMPONENT CIRCUITRY AFTER IT LEAKED FROM THE RESERVOIR. ADDITIONAL INFORMATION WILL BE COMMUNICATED AROUND ANY OTHER CAUSAL FACTORS AND CORRECTIVE ACTIONS AS IT BECOMES AVAILABLE. REVIEW OF THE COMPLAINT HISTORY FOR THIS PRODUCT FOR THE PERIOD (B)(4) 2010 TO PRESENT RETURNED NO OTHER INCIDENT REPORTED GLOBALLY WITHIN THAT TIME FRAME WITH THIS FAILURE MODE REPORTED THAT RESULTED IN SIGNIFICANT DAMAGE TO AN INSTRUMENT. THE INVESTIGATION INTO THIS INCIDENT IS ONGOING TO INCLUDE REVIEW OF THE PROCESS USED BY THE SUPPLIER TO MANUFACTURE THE RESERVOIR. ADDITIONAL INFORMATION WILL BE REPORTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    VENTANA MEDICAL SYSTEMS, INC. RECEIVED A CUSTOMER COMPLAINT REGARDING FLUID FROM A SOURCE INTERNAL TO A BENCHMARK ULTRA AUTOMATED SLIDE STAINER CONTACTING THE ELECTRICAL CIRCUITRY OF THE STAINER RESULTING IN A SHORT CIRCUIT AND ENOUGH HEAT TO CAUSE SOME MELTING OF WIRING INSULATION RESULTING IN SOME SMOKE BEING EMITTED. THERE WERE NO SERIOUS INJURIES OR DEATH ASSOCIATED WITH THE INCIDENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1