BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETRACE

    MDR report key: 214281 · Received March 8, 1999

    Report

    Report Number
    2951268-1999-00001
    Event Type
    Malfunction
    Date Received
    March 8, 1999
    Date of Event
    February 11, 1999
    Report Date
    March 8, 1999
    Manufacturer
    WYNDGATE TECHNOLOGIES DIVISION GLOBAL MED TECHNOLOGIES, INC
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUMMARY: DONOR DEFERRAL PROHIBTING FACTORS ARE BEING REMOVED IMPROPERLY FROM "LIVE" COMPONENTS WHEN DEFERRAL RECORDS WHOSE STATUS IS EXPIRED EXIST ON THE DONOR DEFERRALS (DNMDP) SCREEN AND A NEW DEFERRAL IS POSTED ON THE DONOR DEFERRAL POSTING (DNMDP) WINDOW OR A DEFERRAL STATUS IS CHANGED TO EXPIRED ON THE DONOR DEFERRALS SCREEN. DETAILS: THIS CAN RESULT IN A "LIVE" COMPONENT NOT HAVING A DONOR DEFERRAL PROHIBITING FACTOR WHEN THE COMPONENTS DRAW DATE IS WITHIN THE RANGE OF THE DATES BETWEEN THE DEFERRAL EFFECTIVE DATE AND THE DONOR ELIGIBLITITY DATE OD AN EXPIRED DEFERRAL FOR THE DONOR. AN EXAMPLE SCENARIO OF THE ISSUE IS DETAILED BELOW:A DONOR DONATES ON 06/01/98 AND HAS TEMPORARY DEFERRAL POSTED WITH AN EFFECTIVE DATE OF 06/01/98 AND AN ELIGIBILITY DATE OF 12/01/98. A COMPONENT, WHICH WILL EXPIRE ON A DATE GREATER THAN 12/01/98, IS CREATED FROM THE DONATION. THE COMPONENT RECEIVES THE DONOR DEFERRAL PROHIBITING FACTOR AND IS PLACED INTO PENDING QUARANTINE. THE ISSUE CAN NOW OCCUR IN TWO DIFFERENT SITUATIONS.1. ON A DATE EQUAL TO OR GREATER THAN THE ELIGIBILITY DATE OF THE DEFERRAL BUT LESS THAN THE EXPIRATION DATE OF THE COMPONENT, THE DEFERRAL STATUS IS CHANGED TO EXPIRED ON THE DONOR DEFERRALS SCREEN. THIS RESULTS IN THE DONOR DEFERRAL PROHIBITING FACTOR BEING REMOVED FROM THE COMPONENT. 2. THE DNR DEFRRALS CD REMOVEL/STAT UPDATE BATCH JOB IS EXECUTED TO UPDATE THE STATUS OF THE DEFERRAL TO EXPIRED ON A GREATER THAN THE ELIGIBILITY DATE OF THE DEFERRAL DECORD. POST A NEW DEFERRAL FOR THE DONOR WITH THE DONOR DEFERRAL POSTING WINDOW. THIS RESULTS IN THE DONOR DEFERRAL PROHIBITING FACTOR BEING REMOVED FROM THE COMPONENT. RESOLUTION: UNTIL THIS ISSUE HAS BEEN RESOLVED DO NOT RUN THE DNR DEFERRAL CD REMOVAL/STAT UPDATE BATCH JOB OR CHANGE DEFERRALS TO AN EXPIRED STATUS ON THE DONOR DEFERRALS SCREEN. WHEN EVALUATING COMPONENTS IN PENDING QUARANTINE YOU MUST REVIEW THE PROHIBITING FACTOR HISTORY, CHECKING FOR DELETED DONOR DEFERRAL FACTORS, PRIOR TO MOVING THE COMPONENTS OUT OF QUARANTINE IF YOU ARE NOT CURRENTLY DOING THIS ACCORDING TO YOUR OPERATING PROCEDURES. A QUERY (OR QUERIES) TO IDENTIFY UNITS THAT HAVE BEEN AFFECTED BY THIS ISSUE AND DONORS THAT ARE CANDIDATES FOR THIS ISSUE ARE CURRENTLY BEING DEVELOPED. THIS QUERY ( OR QUERIES) WILL BE SENT TO YOUR SITE AS SOON AS IT IS AVAILABLE. THIS ISSUE WILL BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETRACE SOFTWARE, BLOOD BANK DONOR, STAND ALONE MMH WYNDGATE TECHNOLOGIES DIVISION GLOBAL MED TECHNOLOGIES, INC VERSION 1.1.015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *