BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA STAINER MODULE

    MDR report key: 2719328 · Received August 29, 2012

    Report

    Report Number
    2028492-2012-00001
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    July 30, 2012
    Report Date
    July 30, 2012
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN RETURNED FROM THE CUSTOMER SITE IS BEING EXAMINED IN DETAIL. AS OF THE DATE OF THIS REPORT A DEFINITIVE CAUSE OF THE FLUID CONTACT WITH THE CIRCUIT BOARD THAT IS VISIBLY DAMAGED HAS NOT BEEN ESTABLISHED. A FOLLOW-UP REPORT WILL BE ISSUED PENDING THE OUTCOME OF THE INVESTIGATION INTO ROOT CAUSE OF THE LEAK.

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE INCIDENT ORIGINALLY REPORTED UNDER 2028492-2012-0001 WAS DETERMINED TO BE A BUILD-UP OF DEBRIS IN THE WASTE FLUID DISCHARGE SYSTEM. A NOTIFICATION HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR, HOW TO RECOGNIZE IF THE WASTE DISCHARGE SYSTEM IS BECOMING RESTRICTED AND TO REMIND THEM TO PERFORM PERIODIC CLEANING OF THE SYSTEM. A CAPA HAS BEEN OPENED TO PURSUE ADDITIONAL CORRECTIVE ACTION(S).

    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