BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2927173 · Received January 16, 2013

    Report

    Report Number
    9610825-2012-00301
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 18, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). (B)(4). IN A F/U CALL TO THE FACILITY, THE REPORTER STATED THAT HE CURRENTLY HAS THE PUMP AND IT WILL BE RETURNED FOR EVAL WHEN IT IS RELEASED BY THEIR FACILITY. THE REPORTER STATED THAT THE ACTUAL IV SET INVOLVED WAS ALSO RETURNED ALONG WITH THE PUMP BUT THE SET WAS NOT LOADED IN THE PUMP WHEN HE RECEIVED IT. THE REPORTER WAS UNABLE TO COMMENT ON THE PT'S CONDITION. AS OF THIS TIME, THE ACTUAL PUMP AND IV SET INVOLVED IN THE INCIDENT HAVE NOT BEEN RECEIVED FOR EVAL. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: SERIAL # (B)(4). OVER INFUSION OF UNK THERAPY. MEDWATCH #230104-2012-0002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24130 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other