BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48

    MDR report key: 10718650 · Received October 22, 2020

    Report

    Report Number
    2022180-2020-00362
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 14, 2020
    Report Date
    October 14, 2020
    Manufacturer
    DAKO NORTH AMERICA, INC.
    Product Code
    KPA
    UDI-DI
    05700572035497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THIS MEDWATCH WAS SENT PREVIOUSLY ON 14/OCT/2020 WITH INCORRECT MEDWATCH NUMBER OF 2022180-2020-00358. ROOT CAUSE: POTENTIAL ALTERATION OF STAINING IN THIS CASE WAS DUE TO IMPROPER OPERATION OF THE DISPENSE CHECK VALVE (3 PSI ONE WAY VALVE). THE PROBLEM WAS SOLVED BY FIELD SERVICE ENGINEER WITH REPLACEMENT OF THE PART. FOLLOWING THE REPLACEMENT, THE INSTRUMENT WAS FULLY OPERATIONAL WITHIN SPECIFICATIONS, WITHOUT ERRORS AND AVAILABLE FOR THE USER. FAILURE MODE DESCRIPTION: FOLLOWING A DISPENSE CHECK VALVE MALFUNCTION OR IF THE PART STOPS WORKING; THE RESULTING FAILURE MODE COULD OCCUR. SMALL LEAK COULD RESULT IN DROPS OF BUFFER FROM THE PROBE AFTER WASH OR DISPENSING ABERRATION RESULTING IN LOW VOLUME DISPENSED (FIRST DISPENSE). THIS FAILURE MODE HAS THE POTENTIAL TO ALTER STAINING.

    Description of Event or Problem · 1

    BASED ON COMPLAINT REPORT OR INVESTIGATED FAILURE MODE, THERE WAS POTENTIAL FOR A STAINING ALTERATION. CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: PROBE LEAKING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182658 AUTOSTAINER LINK 48 AUTOSTAINER LINK 48 KPA DAKO NORTH AMERICA, INC. AS480 05700572035497

    Patients

    Seq Age Sex Outcome Treatment
    1