BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2193253 · Received July 29, 2011

    Report

    Report Number
    9610825-2011-00096
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE ACTUAL PUMP HAS NOT YET BEEN EVALUATED. THE MFR'S INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS ON (B)(6), A PT WAS ON A BUMEX DRIP AT 1ML/HR. THERE WAS 20 ML LEFT IN THE BAG AND IN 1 HOUR, THE BAG WAS EMPTY. THE PT WAS OKAY. DRUG WAS NOT IN THE DRUG LIBRARY. PUMPS WERE LOOKED AT BY THEIR BIOMED DEPT. IT APPEARS THAT THE PROGRAMMING OF THE PUMPS WAS CORRECT. THEY CANNOT DETERMINE A CAUSE FOR THE OVER INFUSIONS. THE PUMPS ARE NOW WITH A 3RD PARTY FOR ANOTHER ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other