BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD BANK CONTROL SYSTEM (BBCS)

    MDR report key: 843092 · Received April 30, 2007

    Report

    Report Number
    3028885-2007-00001
    Event Type
    Malfunction
    Date Received
    April 30, 2007
    Report Date
    April 20, 2007
    Manufacturer
    BLOOD BANK COMPUTER SYSTEMS, INC.
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK MITIGATION HAS BEEN REPAIRED BY: EXPANDING THE EDITS FOR ERROR MESSAGE BBCS-4585 TO INCLUDE VERIFICATION THAT RESPONSES WHICH REQUIRE SCREENER INTERVENTION ARE PERFORMED. THE QUESTIONNAIRE SUMMARY HAS BEEN ENHANCED TO DISPLAY SUGGESTED DEFERRALS RELATED TO NON-REVIEWED QUESTIONS. NO KNOWN ADVERSE EVENTS HAVE OCCURRED AS A RESULT OF THIS ISSUE. THERE IS NO DIRECT IMPACT ON PT CARE. PROPOSED STRATEGY: ALL DIRECT CONTACTS HAVE BEEN NOTIFIED AND DEVICE CORRECTION HAS BEEN SHIPPED. EVAL SUMMARY: BBCS HAS EVALUATED THE DEVICE AND DETERMINED THAT THE PROGRAM IS WORKING AS DESIGNED. THE DESIGN REQUIRES MODIFICATION TO THE USER INTERFACE.

    Description of Event or Problem · 1

    IT HAS BEEN DETERMINED THAT AN ERROR EXISTS IN THE RISK MITIGATION FOR THE FOLLOWING CAUSE: DEFERRAL NOT POSTED BASED ON QUESTION RESPONSES. WHEN THE FOLLOWING CONDITIONS OCCUR: THE DONOR UTILIZES THE SRQ MODULE (BBC084) AND ENTERS A RESPONSE WHICH SHOULD RESULT IN A DEFERRAL. THE QUESTION DOESN'T REQUIRE A FOLLOW UP QUESTION TO BE PRESENTED TO THE SCREENER IN FUNCTION #087. THE SCREENER PRESSES THE F10 KEY TO JUMP DIRECTLY TO THE QUESTIONNAIRE SUMMARY SCREEN FOLLOWED BY PRESSING THE F2 TO UPDATE THE RECORD. THE SCREENER DOESN'T REVIEW THE INDIVIDUAL QUESTION DETAIL RECORDS IN FUNCTION #087. THE FOLLOWING ERROR MESSAGE IS NOT BEING DISPLAYED: 'BBCS-4585 A RESPONSE HAS NOT BEEN RECORDED FOR ALL REQUIRED QUESTIONS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD BANK CONTROL SYSTEM (BBCS) BLOOD BANK SOFTWARE MMH BLOOD BANK COMPUTER SYSTEMS, INC. * 5.0,5.1,5.2,5.2.1,5.2.2, POD00

    Patients

    Seq Age Sex Outcome Treatment
    1 *