BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGULATED SOFTWARE APPLICATION (RSA)

    MDR report key: 9488760 · Received December 18, 2019

    Report

    Report Number
    1077496-2019-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 11, 2019
    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
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A SOFTWARE MODIFICATION WAS PERFORMED, VERIFIED, AND VALIDATED. THE SCOPE OF TESTING INCLUDED THE SOFTWARE MODIFICATION ITSELF, ALL POTENTIALLY IMPACTED AREAS OF THE SOFTWARE, AND REGRESSION TESTING TO ENSURE THAT THE FIX WAS EFFECTIVE AND DID NOT ADVERSELY AFFECT THE SOFTWARE. THIS SOFTWARE MODIFICATION WAS IMPLEMENTED ON (B)(6) 2019 AS V1.0.32.1. 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 ISSUES ARE CURRENTLY WORKING WITH THE UPDATED SOFTWARE APPLICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ONEBLOOD BECAME AWARE THAT UNDER RARE ATYPICAL NONCOMPLIANT CIRCUMSTANCES, RSA WILL NOT PREVENT A USER FROM COLLECTING BLOOD FROM A DONOR WITH A HEMOGLOBIN (HGB) BELOW THE LOWER ACCEPTABLE LIMIT. THE SOFTWARE ANOMALY IN QUESTION TAKES PLACE DURING THE PROCESS OF ENTERING A DONOR'S "PHYSICAL EXAM" INFORMATION, WHICH INCLUDES DATA SUCH AS BLOOD PRESSURE, PULSE, TEMPERATURE, WEIGHT, HEIGHT, AND HGB. RSA PROVIDES A WAY FOR USERS TO ENTER A SECOND HGB VALUE IF THE FIRST VALUE PROVIDED WAS TOO LOW TO MEET DONATION ELIGIBILITY REQUIREMENTS (AS DETERMINED BY SOFTWARE VALIDATION), AND THE USER DETERMINES THAT A REPEAT TEST IS APPROPRIATE BASED ON BLOOD CENTER SOP. IN RARE SITUATIONS, THE SYSTEM VALIDATION IS NOT APPLYING A DONOR DEFERRAL AUTOMATICALLY, WHICH WOULD PREVENT INELIGIBLE COLLECTION WHEN A SECOND, LOW, HGB VALUE IS ENTERED AND A DONOR HEIGHT VALUE IS NOT. 0 UNITS WERE COLLECTED FROM DONORS WHO HAD HGB LEVELS TOO LOW TO MEET ELIGIBILITY CRITERIA. HOWEVER, 68 DONOR RECORDS WERE IDENTIFIED AS HAVING NO AUTOMATIC DEFERRALS PLACED ON THEM DUE TO THE ABOVE SCENARIO; EACH OF THE 68 WERE DISCOVERED BY STAFF AT THE PROPER TIME AND THE DONATION PROCESSES CEASED. THE DONOR INFORMATION WAS GIVEN TO THE RECORD REVIEW DEPARTMENT, AND PROPER DEFERRALS WERE APPLIED MANUALLY. MDR IS BEING FILED AS AN INADVERTENT COLLECTION OF THESE UNITS COULD POTENTIALLY RESULT IN ADVERSE EVENT(S) IF NOT IDENTIFIED AND CORRECTED. THE DEFICIENT CODE WAS INTRODUCED IN SOFTWARE VERSION 1.0.32.0, RELEASED ON 11/17/2019. ON (B)(6) 2019, ONEBLOOD BECAME AWARE THAT UNDER RARE ATYPICAL NONCOMPLIANT CIRCUMSTANCES, RSA WILL NOT PREVENT A USER FROM COLLECTING BLOOD FROM A DONOR WITH A HEMOGLOBIN (HGB) BELOW THE LOWER ACCEPTABLE LIMIT. THE SOFTWARE ANOMALY IN QUESTION TAKES PLACE DURING THE PROCESS OF ENTERING A DONOR'S "PHYSICAL EXAM" INFORMATION, WHICH INCLUDES DATA SUCH AS BLOOD PRESSURE, PULSE, TEMPERATURE, WEIGHT, HEIGHT, AND HGB. RSA PROVIDES A WAY FOR USERS TO ENTER A SECOND HGB VALUE IF THE FIRST VALUE PROVIDED WAS TOO LOW TO MEET DONATION ELIGIBILITY REQUIREMENTS (AS DETERMINED BY SOFTWARE VALIDATION), AND THE USER DETERMINES THAT A REPEAT TEST IS APPROPRIATE BASED ON BLOOD CENTER SOP. IN RARE SITUATIONS, THE SYSTEM VALIDATION IS NOT APPLYING A DONOR DEFERRAL AUTOMATICALLY, WHICH WOULD PREVENT INELIGIBLE COLLECTION WHEN A SECOND, LOW, HGB VALUE IS ENTERED AND A DONOR HEIGHT VALUE IS NOT. 0 UNITS WERE COLLECTED FROM DONORS WHO HAD HGB LEVELS TOO LOW TO MEET ELIGIBILITY CRITERIA. HOWEVER, 68 DONOR RECORDS WERE IDENTIFIED AS HAVING NO AUTOMATIC DEFERRALS PLACED ON THEM DUE TO THE ABOVE SCENARIO; EACH OF THE 68 WERE DISCOVERED BY STAFF AT THE PROPER TIME AND THE DONATION PROCESSES CEASED. THE DONOR INFORMATION WAS GIVEN TO THE RECORD REVIEW DEPARTMENT, AND PROPER DEFERRALS WERE APPLIED MANUALLY. MDR IS BEING FILED AS AN INADVERTENT COLLECTION OF THESE UNITS COULD POTENTIALLY RESULT IN ADVERSE EVENT(S) IF NOT IDENTIFIED AND CORRECTED. THE DEFICIENT CODE WAS INTRODUCED IN SOFTWARE VERSION 1.0.32.0, RELEASED ON 11/17/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286532 REGULATED SOFTWARE APPLICATION (RSA) BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH ONEBLOOD, INC. 1.0.32.0 00860664000309

    Patients

    Seq Age Sex Outcome Treatment
    1 Other