BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2932429 · Received January 8, 2013

    Report

    Report Number
    9610825-2012-00288
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    October 25, 2012
    Report Date
    December 10, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) A (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY (B)(4)): THE UNIT OF BLOOD WAS TRANSFUSED VIA A BRAUN PUMP TO A PT IN 1 HOUR IN ERROR AND THE PUMP WAS SET TO TRANSFUSE THE UNIT OVER 4 HOURS. THE PUMP SCREEN DISPLAYED 3 HRS LEFT TO TRANSFUSE AT THIS STAGE. AS THE UNIT WAS TRANSFUSED TOO QUICKLY THE MALFUNCTION OF THE PUMP PUT THE PT AT RISK OF TRANSFUSION OVERLOAD. THE PT WAS MONITORED CLOSELY AFTERWARDS. THIS EVENT WAS REPORTED TO THE NATIONAL HAEMOVIGILANCE OFFICE AS PER PROTOCOL. THE PUMP IN QUESTION WAS SENT TO THE COMPANY OF MANUFACTURE AND WAS NOT USED AFTER THIS EVENT AS IT WAS WITHDRAWN FROM SERVICE IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10246 INFUSOMAT SPACE INFUSION PUMP FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other