BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48

    MDR report key: 10800978 · Received November 6, 2020

    Report

    Report Number
    2022180-2020-00377
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 5, 2020
    Manufacturer
    DAKO NORTH AMERICA, INC
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: POTENTIAL ALTERATION OF STAINING IN THIS CASE WAS DUE TO IMPROPER OPERATION OF THE 2-WAY PINCH VALVE (992390). 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 2-WAY PINCH VALVE (992390) MALFUNCTION OR IF THE PART STOPS WORKING; THE RESULTING FAILURE MODES COULD OCCUR: NO OR INSUFFICIENT BUFFER/WATER RINSE. THIS FAILURE MODE HAS THE POTENTIAL TO DELAY DIAGNOSIS AND A POSSIBLE RE-BIOPSY IF RESERVE TISSUE SAMPLES ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: BUFFER VOLUME NOT WITHIN SPECIFICATION. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264454 AUTOSTAINER LINK 48 AUTOSTAINER LINK 48 KPA DAKO NORTH AMERICA, INC AS480

    Patients

    Seq Age Sex Outcome Treatment
    1