BEUDAMED
    FDA Adverse Event Other Summary report: N

    HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION

    MDR report key: 2000385 · Received February 7, 2011

    Report

    Report Number
    1931259-2011-00002
    Event Type
    Other
    Date Received
    February 7, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 7, 2011
    Manufacturer
    CERNER CORP
    Product Code
    MMH
    PMA / PMN Number
    BK990007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERNER PUBLISHED PRIORITY REVIEW FLASH NOTIFICATION (B)(4) ON (B)(4) 2011 TO NOTIFY ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND ALSO INCLUDES THE WORKAROUND CLIENTS CAN USE TO IDENTIFY AND REMOVE ISBT ALIASES UNTIL THE PERMANENT SOFTWARE CORRECTION IS AVAILABLE. THE FLASH ALSO NOTIFIES CLIENTS THAT CERNER IS RELEASING THE FOLLOWING PACKAGES TO CORRECT THE ISSUE: (B)(4). CERNER CORP CONSIDERS THIS ISSUE RESOLVED AND NO FURTHER NARRATIVE IS REQUIRED FOR FOLLOW-UP.

    Description of Event or Problem · 1

    THE ISSUE INVOLVES FUNCTIONALITY WITHIN THE CERNER HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION SOFTWARE SOLUTION AND OCCURS WITHIN THE DISPENSE AND ASSIGN AND BLOOD BANK RESULT ENTRY APPLICATIONS WHEN A PT HAS A TRANSFUSION REQUIREMENT FOR A LEUKOREDUCED OR WASHED ATTRIBUTE AND ALSO HAS A TRANSFUSION REQUIREMENT FOR AN ADDITIONAL BLOOD PRODUCT ATTRIBUTE, SUCH AS IRRADIATED OR CMV NEGATIVE, AND THE SELECTED PRODUCT HAS THE LEUKOREDUCED OR WASHED ATTRIBUTE BUT DOES NOT HAVE THE ADDITIONAL ATTRIBUTE, THE SYSTEM MAY NOT DISPLAY A WARNING MESSAGE INDICATING THAT THE BLOOD PRODUCT DOES NOT HAVE THE ADDITIONAL ATTRIBUTE. FOR THE REPORTING CLIENT, THERE WERE TWO INSTANCES WHERE THE WARNING MESSAGE WAS NOT DISPLAYED FOR SICKLE CELL NEGATIVE UNITS; HOWEVER, THE CLIENT INDICATED TO CERNER THAT THE PRODUCTS DID MEET REQUIREMENTS AND WERE ACCEPTABLE FOR THE PTS, BUT THE TESTING WAS JUST NOT DOCUMENTED IN THE COMPUTER SYSTEM. NEITHER INCIDENT RESULTED IN PT HARM. CERNER HAS NOT RECEIVED ANY REPORTS OF PT INJURY OR DEATH IN RELATION TO THIS ISSUE FROM OTHER CLIENT SITES. THE WARNING MESSAGE IS ONLY A SUPPLEMENTAL LAYER OF ADDED PROTECTION FOR THE BLOOD BANK AND PT. THE BLOOD BANKER CAN SEE ALL THE REQUIRED BLOOD PROPERTIES IN THE HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION SYSTEM BEFORE RELEASING UNITS TO THE PT AND IN NEARLY ALL CASES DISPLAY OF THE WARNING MESSAGE WOULD NOT BE NEEDED. UNTIL A SOFTWARE CORRECTION IS AVAILABLE, CLIENTS CAN PREVENT THE ISSUE FROM OCCURRING BY REMOVING ISBT ALIASES FOR LEUKOREDUCED AND WASHED ATTRIBUTES IN THEIR HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION PATHNET BLOOD BANK TRANSFUSION MMH CERNER CORP VERSION 2010.01.05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other