BEUDAMED
    FDA Adverse Event Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3769866 · Received April 17, 2014

    Report

    Report Number
    2523676-2014-00113
    Date Received
    April 17, 2014
    Date of Event
    July 24, 2013
    Report Date
    March 21, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: "RESETTING B-BRAUN IV PUMP AT 0600. PUMP GAVE ALARM ERROR CODE, SAID TO CLOSE ROLLER CLAMP AND TURN PUMP OFF. CHANGED IVFS TO ANOTHER PUMP IMMEDIATELY. INFANT'S SA02 DROPPED TO LOW TO MID 60S WITHIN 5-10 MINUTES OF INCIDENT. (IVFS (TPN) WERE BACKING THE INFANTS PGE DRIP). SA02 RECOVERED WITHIN 5-10 MINUTES TO BASELINE OF 77%." PLEASE REFER MFR REPORT #9610825-2014-00113.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236901 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK