BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTBANK II

    MDR report key: 3413314 · Received October 10, 2013

    Report

    Report Number
    MW5032239
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    September 20, 2013
    Report Date
    October 9, 2013
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE BLOOD BANK INFO SYSTEM (BBIS), SOFTBANK II V.25.1, HAD ALLOWED UNITS OF RED BLOOD CELLS (RBC) TO BE INAPPROPRIATELY ISSUED FOR PT TRANSFUSION WITHOUT THE REQUIRED COMPATIBILITY TEST. INVESTIGATION SHOWED THAT THE COMPUTER HAD ERRONEOUSLY ALLOWED 20 UNITS OF RBC TO BE SELECTED AND PREPARED FOR TRANSFUSION TO 11 PTS BETWEEN (B)(6) 2013 WITHOUT AN ELECTRONIC CROSSMATCH. IN ADDITION, 6 OF THE 20 RBCS WERE ISSUED TO 3 PTS WITHOUT REQUIRING OR PERFORMING AN ELECTRONIC CROSSMATCH. ALL OF THESE UNITS WERE ELECTRONIC CROSSMATCH COMPATIBLE WITH THE RESPECTIVE PTS. THREE OF THESE PRODUCTS WERE TRANSFUSED TO THREE DIFFERENT PTS. IN ALL CASES, THE PRINTED TRANSFUSION TAG LABELS DISPLAYED A CROSSMATCH INTERPRETATION OF 'NOT REQUIRED.' AS ALL OF THESE UNITS WERE COMPATIBLE, THE UNITS WERE TRANSFUSED WITHOUT INCIDENT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517799 SOFTBANK II SOFTBANK II MMH SCC SOFT COMPUTER VERSION 25.1.0.4.21

    Patients

    Seq Age Sex Outcome Treatment
    1 Other