BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCARE BLOOD BANK DATA MANAGEMENT SYSTEM

    MDR report key: 278046 · Received May 11, 2000

    Report

    Report Number
    2437251-2000-00007
    Event Type
    Malfunction
    Date Received
    May 11, 2000
    Report Date
    May 10, 2000
    Manufacturer
    MEDIWARE INFO SYSTEMS, HEMOCARE PRODUCT CENTER
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE DONOR SUBSYSTEM, MEDICAL INTERVIEW FUNCTION RECORDS THE MEDICAL INTERVIEWER'S DETERMINATION OF A DONOR'S ELIGIBILITY TO DONATE ON A SPECIFIC DONATION DATE. AN OPTIONAL CODED "DIAGNOSIS" FIELD CAN BE USED TO RECORD A DIAGNOSIS IF THE DONOR WAS DEEMED INELIGIBLE TO DONATE ON THAT DONATION DATE (IN ADDITION TO THE MANDATORY DEFERRAL CODE THAT MUST BE RECORDED). IF THIS DONOR WERE TO RETURN TO DONATE AFTER THE DEFERRAL PERIOD HAS ENDED AND SELECTED FOR MEDICAL INTERVIEW, THE PREVIOUSLY RECORDED DIAGNOSIS CODE WILL NOT DISPLAY. ADDITIONALLY, IF THIS DONOR IS DEEMED ELIGIBLE TO DONATE, THE PROGRAM FLOW INCORRECTLY GOES TO THE DIAGNOSIS CODE FIELD, WHICH APPEARS BLANK. IF THE USER CARRIAGE RETURNS THROUGH THIS FIELD, THE DIAGNOSIS CODE IS DELETED FROM THE RECORD. THE DIAGNOSIS CODE, WHICH IS NOT DISPLAYED IN MEDICAL INTERVIEW, MAY ASSIST IN THE DONOR SUITABILITY DECISION. THE DELETION OF THE DIAGNOSIS CODE MAY ALLOW AN INAPPROPRIATE DONATION TO TAKE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCARE BLOOD BANK DATA MANAGEMENT SYSTEM SOFTWARE, BLOOD BANK, STAND ALONE MMH MEDIWARE INFO SYSTEMS, HEMOCARE PRODUCT CENTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *