BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH MAGIC BBK MODULE

    MDR report key: 600750 · Received June 14, 2004

    Report

    Report Number
    1222805-2004-00001
    Event Type
    Malfunction
    Date Received
    June 14, 2004
    Report Date
    June 10, 2004
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDITECH HAS IDENTIFIED A SAFETY CONCERN WITH VERSION 4.9 AND VERSION 5.4 OF THE MEDITECH MAGIC BLOOD BANK MODULE. THESE VERSIONS OF MARKETED BLOOD ESTABLISHMENT COMPUTER SOFTWARE COULD ALLOW THE RELEASE OF UNSUITABLE BLOOE PRODUCTS. IN 2004, FACILITY REPORTED THAT THE MEDITECH MAGIC BLOOD BANK MODULE SHOWED AN INCORRECT STATUS ON ONE UNIT OF BLOOD PRODUCT. FURTHER DETAILS REVEALED THAT THE UNIT OF FRESH FROZEN PLASMA (KC57726) HAD BEEN ASSIGNED TO TWO PT'S SPECIMENS AS A PREPARATORY STEP TO POSSIBLY ADMINISTERING THE COMPONENT TO ONE OF THE PTS. THE UNIT WAS GIVEN A FINAL STATUS OF "DISCARDED" 6 DAYS AGO AT 1531 AND THE UNIT WAS UNASSIGNED FROM THE TWO PT SPECIMENS. AT THE SITE, A SCHEDULED BLOOD BANK ROUTINE RUNS PERIODICALLY IN THE BACKGROUND TO FIND "ASSIGNED" UNITS AND THE AUTOMATICALLY UNASSIGN THEM FROM PT SPECIMENS IF THEY HAVE NOT BEEN ADMINISTERED. 2 DAYS LATER AT 2355, THE SCHEDULED BLOOD BANK ROUTINE ERRONEOUSLY SELECTED THE "DISCARDED" UNIT AND CHANGED IT BACK TO "ASSIGNED", THEN IMMEDIATELY UPDATE THE UNIT'S STATUS TO "EXPIRED", BASED ON ITS 72-HOUR EXPIRATION. THE UNIT OF FRESH FROZEN PLASMA WAS NOT ADMINISTERED TO ANY PTS. IT SHOULD ALSO BE NOTED THAT THE BLOOD BANK'S PROCEDURES WOULD BE TO IMMEDIATELY PULL ANY "DISCARDED" UNIT FROM STORAGE AND QUARANTINE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH MAGIC BBK MODULE MMH - SOFTWARE, BLOOD BANK MMH MEDICAL INFORMATION TECHNOLOGY, INC. 4.9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA