BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 3950024 · Received July 22, 2014

    Report

    Report Number
    1034569-2014-00125
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 21, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT INTERVIEWED THE CUSTOMER ON (B)(4) 2014 REGARDING THE INSTRUMENT AND ALSO THE TESTING OUTCOMES. CUSTOMER WAS UNABLE TO RETURN BLOOD SAMPLES OR PRODUCT BACK TO THE IMMUCOR LABORATORY FOR INVESTIGATION. AN IMMUCOR FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE TO ASSESS THE INSTRUMENT. IT WAS FOUND THAT THE WASHER MANIFOLD TUBE CONNECTION WAS LOOSE. THIS CONNECTION WAS SUBSEQUENTLY TIGHTENED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTEDLY COMPATIBLE SET OF CROSSMATCHES WHEN TESTING A BLOOD SAMPLE ON A GALILEO ECHO, WITH A SUBSEQUENT POTENTIAL FOR A TRANSFUSION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429138 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR