BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER MILLINEUM

    MDR report key: 1699089 · Received May 17, 2010

    Report

    Report Number
    1699089
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Date of Event
    March 7, 2010
    Report Date
    May 17, 2010
    Manufacturer
    CERNER
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN A CERNER SERVICE PACK WAS LOADED INTO OUR SYSTEM IN MARCH , THE CONTENTS OF THE PACKAGE ADVERSELY AFFECTED THE BLOOD BANK'S ABILITY TO USE THE "PATIENT PRODUCT INQUIRY" FUNCTION (PPI). PPI IS USED BY THE BLOOD BANK TO PERFORM A NUMBER OF PROCESSES, MOST IMPORTANTLY A LISTING OF PATIENT'S TRANSFUSION HISTORY. WITH THIS DEFECT ,WHEN PPI IS SELECTED, THE COMPUTER FREEZES UP AND EVENTUALLY GIVES US AN ERROR MESSAGE. NOT HAVING THE ABILITY TO USE THIS FUNCTION LIMITS THE BLOOD BANK'S ABILITY TO VIEW RECENT TRANSFUSION HISTORY, AS WELL AS BLOOD TYPE, ANTIBODIES, AND OTHER CRUCIAL BLOOD BANK INFORMATION. SOME, BUT NOT ALL, OF THIS INFORMATION CAN BE LOCATED USING OTHER FUNCTIONS, WITH THE MAJOR EXCEPTION OF RECENT TRANSFUSION HISTORY. WHILE THE SCREEN IS FROZEN, WE ARE UNABLE TO USE OTHER CERNER BLOOD BANK FUCNTIONS. IN ADDITION, AT TIMES, WE HAVE HAD MULTIPLE COMPUTER TERMINALS TIED UP AND UNAVAILABLE FOR USE UNTIL THESE SCRIPT ERRORS TIME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERNER MILLINEUM HEALTHCARE INFORMATION TECHNOLOGY COMPUTING PLATFORM MMH CERNER CERNER MILLINEUM 2010.1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *