BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGULATED SOFTWARE APPLICATION (RSA)

    MDR report key: 9488908 · Received December 18, 2019

    Report

    Report Number
    1077496-2019-00001
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 6, 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, 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 11/20/2019 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 ISSUE ARE CURRENTLY WORKING WITH THE UPDATED SOFTWARE APPLICATION

    Description of Event or Problem · 1

    DESCRIBE EVENT: ON (B)(6) 2019, ONEBLOOD BECAME AWARE THAT UNDER RARE ATYPICAL NONCOMPLIANT USER CIRCUMSTANCES, RSA WILL NOT PREVENT A USER FROM FURTHER MANUFACTURING A WHOLE BLOOD PARENT PRODUCT AFTER THE PARENT PRODUCT WAS DISCARDED. THIS OCCURS WHEN THE USER INCORRECTLY SELECTS THE WRONG PRODUCT (WB PARENT) IN STERILE CONNECTION, AND THEN DISCARDS THE WB PARENT AT THE COMPLETION OF THE STERILE CONNECTION PROCESS INSTEAD OF THE UNSUITABLE CHILD PRODUCT. SIMILARLY, THE SOFTWARE IS NOT PREVENTING THE USERS FROM CARRY OUT A STERILE CONNECTION PROCESS ON A PRODUCT SUCH AS WHOLE BLOOD, WHILE THE PRODUCT WAS ALREADY MANUFACTURED FURTHER INTO INDIVIDUAL COMPONENTS. THEREFORE, IN THESE RARE SITUATIONS, THE SYSTEM IS NOT PREVENTING THE UNSUITABLE CHILD PRODUCT FROM BEING LABELED AND SHIPPED. 2 PRODUCTS WERE LABELED AND SHIPPED BUT WERE SUCCESSFULLY EITHER RECALLED OR DISCARDED AT THE HOSPITAL. 11 TOTAL PRODUCTS HAVE BEEN IDENTIFIED AS AFFECTED UNDER THIS SCENARIO. 5 OF THESE PRODUCTS WERE DISCARDED IN HOUSE AND NEVER SHIPPED. 4 ADDITIONAL PRODUCTS WERE SHIPPED BUT INVESTIGATION INTO THEM DETERMINED THE SHIPPED PRODUCT TO BE SUITABLE AND ONLY REPRESENT AN ERROR IN DOCUMENTATION. MDR IS BEING FILED AS AN INADVERTENT RELEASE OF THESE UNITS COULD POTENTIALLY RESULT IN ADVERSE EVENT(S) IF NOT IDENTIFIED AND CORRECTED. THE DEFICIENT CODE WAS INTRODUCED WITH THE RELEASE OF RSA V1.0.0.0 (9/1/2011) BUT THE LOGIC WAS A CARRYOVER FROM V0.1.0.0 (2006) PREDATING THE CURRENT APPLICABLE 510(K). THE SOFTWARE WAS MISSING VALIDATION LOGIC THAT WOULD PREVENT A CHILD PRODUCT FROM GOING THROUGH FURTHER MANUFACTURING AFTER THE PARENT PRODUCT WAS DISCARDED IN THE SYSTEM BY ANOTHER PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286533 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