BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELLSKY TRANSFUSION 2022 R3

    MDR report key: 20375996 · Received October 4, 2024

    Report

    Report Number
    3006129391-2024-00001
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 6, 2024
    Report Date
    October 3, 2024
    Manufacturer
    WELLSKY CORPORATION
    Product Code
    MMH
    UDI-DI
    B105TRANSFUSION0
    PMA / PMN Number
    BK230826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WELLSKY TRANSFUSION SOFTWARE CAN CALCULATE THE BLOOD COLLECTION DATE WHEN PROVIDED THE EXPIRATION DATE, BASED ON THE ADMINISTRATOR-CONFIGURED PROPERTIES. UPON INITIAL SOLUTION IMPLEMENTATION, THE ADMINISTRATOR ESTABLISHES THE INTERVAL BETWEEN COLLECTION AND EXPIRATION DATES FOR EACH OF THE DIFFERENT BLOOD PRODUCTS. THIS INTERVAL VARIES DEPENDING ON THE TYPE OF BLOOD PRODUCT ACCORDING TO THE RELEVANT STANDARDS AND THE SPECIFIC BLOOD BANK'S STANDARD OPERATING PROCEDURES. THE COLLECTION DATE IS INTENDED TO PROVIDE INFORMATION ON THE AGE OF THE BLOOD PRODUCT TO USERS WITHIN THE SYSTEM. WHEN BLOOD PRODUCTS ARE POOLED OR MODIFIED BY THE DONOR CENTER PRIOR TO BEING RECEIVED IN THE SOFTWARE A NEW EXPIRATION DATE IS APPLIED TO A BLOOD PRODUCT. FOR EXAMPLE, IRRADIATED RED BLOOD CELLS (RBCS) MAY HAVE AN EXPIRATION DATE OF 28 DAYS FOLLOWING IRRADIATION OR THE ORIGINAL EXPIRATION DATE. BECAUSE THE EXPIRATION DATE FOR THESE PRODUCTS CAN VARY, THE EXPIRATION DATE FOR POOLED OR MODIFIED PRODUCTS CANNOT BE FORMULAICALLY CORRELATED TO A COLLECTION DATE, AND THUS THE COLLECTION DATE CALCULATION FUNCTION SHOULD NOT BE USED FOR THESE TYPES OF PRODUCTS. WELLSKY TRANSFUSION'S USER DOCUMENTATION PROVIDES ADMINISTRATORS GUIDANCE REGARDING BLOOD PRODUCT CONFIGURATION SETTINGS. IN RESPONSE TO THE REPORTED ISSUE, WELLSKY UPDATED THE DOCUMENTATION TO SPECIFICALLY EMPHASIZE THAT COLLECTION DATE CALCULATIONS SHOULD NOT BE USED FOR POOLED OR MODIFIED PRODUCTS.

    Description of Event or Problem · 0

    ON SEPTEMBER 6, 2024, WELLSKY WAS NOTIFIED BY A THIRD PARTY OF A CALCULATION ISSUE WITH THE WELLSKY TRANSFUSION SOFTWARE. THIS ISSUE Y OCCURS WHEN THE BLOOD BANK'S SOFTWARE ADMINISTRATOR ("THE ADMINISTRATOR") CONFIGURES THE SYSTEM TO CALCULATE THE COLLECTION DATE FOR MODIFIED OR POOLED PRODUCTS. WHILE THE SOFTWARE FUNCTIONED AS DESIGNED, THE CONFIGURATION SET BY THE ADMINISTRATOR CAUSED THE COLLECTION DATE TO BE CALCULATED INCORRECTLY. THE ADMINISTRATOR HAD CONFIGURED THE SOFTWARE TO CALCULATE THE COLLECTION DATE FOR IRRADIATED RED BLOOD CELLS 28 DAYS PRIOR TO THE KNOWN EXPIRATION DATE. THIS CONFIGURATION CAUSED THE SOFTWARE TO DISPLAY AN INACCURATE COLLECTION DATE TO END USERS, WHICH CAN BE IMPORTANT INFORMATION FOR IMMUNOCOMPROMISED, NEONATAL, OR AT-RISK PATIENTS BASED ON PHYSICIAN ORDER OR BLOOD CENTER STANDARD OPERATING PROCEDURES. THE DISPLAY OF INACCURATE COLLECTION DATES COULD MISLEAD THE END USER ABOUT THE TRUE AGE OF THE PRODUCT. WHILE NO ADVERSE EVENTS HAVE BEEN ASSOCIATED WITH THIS INCIDENT, THE TRANSFUSION OF BLOOD PRODUCTS THAT EXCEED THE SPECIFIED AGE REQUIREMENTS FOR AT-RISK PATIENTS COULD POTENTIALLY HAVE NEGATIVE RESULTS. PROPER CONFIGURATION, IN ACCORDANCE WITH INSTRUCTIONS FOR USE, MITIGATES THE RISK OF ISSUING OR TRANSFUSING A BLOOD UNIT THAT DOES NOT MEET THE REQUIRED AGE CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602476 WELLSKY TRANSFUSION 2022 R3 WELLSKY TRANSFUSION 2022 R3 MMH WELLSKY CORPORATION B105TRANSFUSION0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other