BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATIONAL BLOOD COMPUTER SOFTWARE (NECS)

    MDR report key: 844090 · Received February 26, 2007

    Report

    Report Number
    1124939-2007-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2007
    Date of Event
    January 25, 2007
    Report Date
    February 26, 2007
    Manufacturer
    AMERICAN NATIONAL RED CROSS
    Product Code
    MMH
    PMA / PMN Number
    BK960030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01/26/2007, A REVIEW BY REQUIREMENTS MANAGEMENT, DETERMINED THAT TWO CONFIGURATIONS WERE INCORRECT AS FOLLOWS: CONVERSION VOLUME: SET TO NO INSTEAD OF YES. EXTENDED EXPIRATION: SET YES INSTEAD OF NO. NBCS CONFIGUARATIONS WERE CORRECTED AND AFFECTED PRODUCTS WERE RECALLED.

    Description of Event or Problem · 1

    IN 2007, THE REPORTER REPORTED THAT THE EXPIRATION DATE OF A PART 5, DIVIDED LEUKOREDUCED RBC (PRODUCT CODE 34365) WAS EXTENDED BEYOND THE ORIGINAL EXPIRATION OF THE PARENT PRODUCT WHEN IT WAS IRRADIATED AND CONVERTED TO PRODUCT CODE 35365. THE EXPECTED EXPIRATION DATE FOLLOWING THIS CONVERSION (FROM 34365 TO 35365) SHOULD BE 28 DAYS FROM THE CONVERSION OR THE EXPIRATION DATE OF THE ORIGINAL NON-IRRADIATED COMPONENT, WHICHEVER IS SHORTER. ON 01/26/2007, A REVIEW BY REQUIRMENTS MANAGEMENT, DETERMINED THAT TWO CONFIGURATIONS WERE INCORRECT AS FOLLOWS: CONVERSION VOLUME: SET TO NO INSTEAD OF YES. EXTENDED EXPIRATION: SET YES INSTEAD OF NO. RESEARCH SHOWED THAT UNITS WERE GIVEN EXTENDED EXPIRATION DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATIONAL BLOOD COMPUTER SOFTWARE (NECS) BLOOD BANKING SOFTWARE - STAND ALONE MMH AMERICAN NATIONAL RED CROSS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * 38KW04397| 38KW09458| 38KW16238| 38KW08996| 38FK38377| 38C28703| WHOLE BLOOD NUMBERS (WBN): 38C14502| 38KT34643| 38KW00793| 38KT45599| 38KT40430| 38KT40423| 38LC95517| 38C21609| 38FM66963| 38FV36816