BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGULATED SOFTWARE APPLICATION (RSA)

    MDR report key: 9517030 · Received December 24, 2019

    Report

    Report Number
    1077496-2019-00003
    Event Type
    Malfunction
    Date Received
    December 24, 2019
    Date of Event
    December 24, 2019
    Report Date
    December 24, 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 DATABASE CHANGE WAS PERFORMED TO DEACTIVATE THE EDITING OF ALL POOLED PLASMA PRODUCTS AND FURTHER PREVENT THIS SCENARIO FROM OCCURRING. 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 DATABASE MODIFICATION WAS IMPLEMENTED ON 12/05/2019. 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 12/04/2019, ONEBLOOD BECAME AWARE THAT UNDER RARE CIRCUMSTANCES, RSA APPLIES AN INCORRECT EXPIRATION DATE TO LIQUID POOLED PLASMA PRODUCTS. THIS ANOMALY ONLY APPLIES THE INCORRECT 1-YEAR EXPIRATION DATE TO LIQUID POOLED PLASMA PRODUCTS IF THE PRODUCT WAS ORIGINALLY MANUFACTURED AS AN 8 OR 24-HOUR FROZEN POOLED PLASMA PRODUCT, WHICH IS THEN EDITED TO A LIQUID POOLED PLASMA PRODUCT. UNDER THIS RARE SITUATION, THE SYSTEM WOULD DETERMINE THE EXPIRATION DATE BASED ON THE INDIVIDUAL POOLED PLASMA PRODUCT EXPIRATION DATE INSTEAD OF THE FINAL POOLED PLASMA PRODUCT EXPIRATION DATE. HOWEVER, WHEN A LIQUID POOLED PLASMA PRODUCT IS ORIGINALLY MANUFACTURED AND LABELED WITHOUT EDITING THE CORRECT 26 DAY EXPIRATION DATE IS APPLIED AND PRINTED ON THE PRODUCT LABEL. 1 UNIT WAS FOUND TO BE AFFECTED AND LABELED WITH THE INCORRECT EXPIRATION DATE; AS A RESULT, 3 PRODUCT BAGS WERE SHIPPED BUT SUCCESSFULLY RETURNED. NO UNSUITABLE PRODUCTS WERE TRANSFUSED TO PATIENTS. ON 12/05/2019, A SOFTWARE DATABASE CHANGE WAS PERFORMED TO DEACTIVATE THE EDITING OF ALL POOLED PLASMA PRODUCTS TO PREVENT THIS SCENARIO FROM REOCCURRING. ADDITIONALLY, THE USER GROUP WAS ADVISED OF THE ISSUE AND THE DISABLEMENT OF THE ERRANT FUNCTIONALITY. THIS MDR IS BEING FILED BECAUSE AN INADVERTENT COLLECTION OF THESE UNITS COULD POTENTIALLY RESULT IN ADVERSE EVENT(S) IF NOT IDENTIFIED AND CORRECTED PRIOR TO THE CORRECTIONS MADE. THE DEFICIENT CODE WAS INTRODUCED IN SOFTWARE VERSION (B)(4), RELEASED ON 07/11/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311942 REGULATED SOFTWARE APPLICATION (RSA) BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH ONEBLOOD, INC. 1.0.32.1 00860664000309

    Patients

    Seq Age Sex Outcome Treatment
    1 Other