BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP

    MDR report key: 1030073 · Received April 15, 2008

    Report

    Report Number
    6000001-2008-00233
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR AT THIS MOMENT IF THE DEVICE IS AVAILABLE FOR EVALUATION OR IF THE CUSTOMER DOWNLOADED THE EVENT HISTORY OF THE DEVICE. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON MARCH 20, 2008, THE CUSTOMER CONTACTED BAXTER TO ADVISE NORMAL SALINE WAS INFUSING VIA A COLLEAGUE VOLUMETRIC INFUSION PUMP WHEN THE PT WAS NOTED TO HAVE EDEMA OF THE ARM. THE PUMP DID NOT ALARM OCCLUSION. THE PT HAD BEEN ADMITTED WITH A RESPIRATORY DIAGNOSIS. NORMAL SALINE WAS INFUSING VIA PERIPHERAL INTRAVENOUS CATHETER (IV) AT 40CC/HOUR. THE PUMP HAD THE PEDS SETTING SELECTED. REPORTEDLY, THE IV INFILTRATED WHILE THE CHILD WAS ASLEEP. WHEN THE PT WOKE, THE MOTHER NOTICED THE INCREASED SIZE OF THE ARM. THE PEDIATRICIAN WAS NOTIFIED. FLUID HAD REPORTEDLY TRAVELED HALF WAY FROM THE ELBOW TO THE SHOULDER AND THE PT'S FINGERS (ALL) WHERE DISCOLORED. THE EDEMA REPORTEDLY DISTORTED THE ENTIRE ARM. THE PT REMAINED HOSPITALIZED FOR MONITORING AND APPLICATION OF COMPRESSES. THE PT HAS BEEN DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Hospitalization| R