BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGULATED SOFTWARE APPLICATION (RSA)

    MDR report key: 6104457 · Received November 15, 2016

    Report

    Report Number
    1077496-2016-00001
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    September 8, 2016
    Report Date
    November 15, 2016
    Manufacturer
    ONEBLOOD, INC.
    Product Code
    MMH
    UDI-DI
    00860664000309
    PMA / PMN Number
    BK110048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFICIENT CODE WAS INTRODUCED WITH THE RELEASE OF RSA V1.0.12.0 ON 05/22/2016. A COMPLAINT PERTAINING TO THIS SYSTEM ISSUE WAS RECEIVED ON (B)(6) 2016. AN INITIAL RISK ASSESSMENT AND INVESTIGATION WAS PERFORMED AND STAFF INCORRECTLY CLASSIFIED THIS COMPLAINT TO A PERIPHERAL DEVICE USED WITH THE SOFTWARE. UPON FURTHER REVIEW ON 10/21/2016, IT WAS IDENTIFIED THAT THIS COMPLAINT WAS INCORRECTLY ASSESSED AND WAS RECLASSIFIED AS A MALFUNCTION. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE THE MISHANDLING OF THIS COMPLAINT. ADDITIONALLY, A REVIEW HAS BEEN CONDUCTED ON ALL OPEN COMPLAINTS TO ENSURE NO OTHER COMPLAINTS HAVE BEEN SIMILARLY MISHANDLED. REVIEW OF THE APPLICATION CODE RESPONSIBLE FOR THE ERRANT FUNCTIONALITY FOUND THE DESIGN WAS MISSING NECESSARY CODING TO CREATE THE PARTICULAR DEFERRAL WHEN TRIGGERED BY THE FIRST LEVEL ANSWER (DIRECT ANSWER TO A PARENT QUESTION). THIS IS A RESULT OF INCORRECT DESIGN METHODS FOR HANDLING THE TWO DHQ RECORDS CREATED DURING THIS PROCESS. NO BLOOD PRODUCTS OR DONORS WERE AFFECTED AS A RESULT OF THE SOFTWARE DESIGN ISSUE. A COMMUNICATION WAS PROVIDED TO ALL USERS OF THE FAILURE SCENARIO. A SOFTWARE MODIFICATION WAS PERFORMED, VERIFIED AND VALIDATED. THE SCOPE OF TESTING INCLUDED THE SOFTWARE MODIFICATION ITSELF, AND ALL POTENTIALLY IMPACTED AREAS OF THE SOFTWARE, AND OTHER REGRESSION TESTING TO ENSURE THAT THE FIX WAS EFFECTIVE AND DID NOT ADVERSELY AFFECT THE SOFTWARE. THE SOFTWARE MODIFICATION WAS IMPLEMENTED ON 10/26/2016. NOTIFICATION OF THE CORRECTION WAS PROVIDED SUBSEQUENT TO IMPLEMENTATION. CURRENTLY, THE BECS IS USED ONLY BY A SINGLE CORPORATE ENTITY. AS SUCH, ALL USERS AFFECTED BY THE ISSUE ARE CURRENTLY WORKING WITH THE UPDATED SOFTWARE APPLICATION.

    Description of Event or Problem · 1

    ON 10/21/2016, ONEBLOOD, INC. IDENTIFIED THAT SPECIFIC USER CIRCUMSTANCES COULD ALLOW A POTENTIALLY INELIGIBLE DONOR TO BE ACCEPTED DESPITE ANSWERING "NO" TO DONOR HISTORY QUESTIONNAIRE (DHQ) QUESTION #1: "ARE YOU FEELING HEALTHY AND WELL TODAY". WHEN A DONOR ANSWERS AN ELECTRONIC DHQ ADMINISTERED VIA A TABLET COMPUTER, THE DHQ IS SUBMITTED FOR REVIEW AND FOLLOW UP WITH THE POTENTIAL DONOR BY A ONEBLOOD HEALTH HISTORY SCREENER. AFTER REVIEW WITH THE DONOR, THE DHQ IS SUBMITTED, THE STAFF MEMBER WILL INVESTIGATE THE ANSWER AND NOT ALLOW THE DONOR TO DONATE AND THE SYSTEM APPLIES ANY APPLICABLE DEFERRALS BASED ON DHQ ANSWERS. FOR DHQS COMPLETED VIA A TABLET, TESTING HAS CONFIRMED THAT THE INTENDED ONE-DAY DEFERRAL THAT SHOULD BE PLACED ON THE DONOR IS NOT BEING APPLIED RESULTING IN A POTENTIALLY INELIGIBLE DONOR TO BE ACCEPTED DESPITE ANSWERING THE DHQ IN A DEFERRABLE WAY. THIS FAILURE SCENARIO HAS BEEN CONFIRMED TO ONLY OCCUR IF THE DHQ RESPONSE TO QUESTION #1 IS ANSWERED BY THE DONOR USING A TABLET. ALL OTHER METHODS OF DHQ COMPLETION HAVE BEEN CONFIRMED TO NOT REPRESENT THIS RISK. ADDITIONALLY, THE FAILURE WOULD ONLY MANIFEST IF STAFF INCORRECTLY ALLOW PROGRESSION OF THE DONATION AFTER HEALTH SCREENING OR THE DONOR ATTEMPTS TO DONATE AGAIN ON THE SAME DAY. REVIEW OF PRODUCTION DATA FOUND THAT NO INAPPROPRIATE DONATIONS HAVE OCCURRED AS A RESULT OF THIS POTENTIAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755743 REGULATED SOFTWARE APPLICATION (RSA) BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH ONEBLOOD, INC. 1.0.20.0 00860664000309

    Patients

    Seq Age Sex Outcome Treatment
    1 Other