BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE PUMP CE ENGLISH VERSION

    MDR report key: 1083322 · Received July 28, 2008

    Report

    Report Number
    6000001-2008-00434
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    January 1, 1901
    Report Date
    July 7, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS REFUSED TO SEND THE PUMP TO BAXTER FOR EVAL.

    Description of Event or Problem · 1

    ON 07/07/2008, BAXTER REC'D A REPORT OF AN INTERRUPTION OF THERAPY WHEN A COLLEAGUE PUMP WAS INFUSING NORADRENALINE TO A PT. THERE WAS NO WARNING. ERROR CODE 810:11 WAS DISPLAYED. THE PATIENT'S BLOOD PRESSURE DROPPED AND WAS "PERI-ARREST." THE PT WAS RESUSCITATED AND WAS REPORTED TO BE DISTRESSED. ALTHOUGH REQUESTED, BAXTER HAS NOT REC'D ANY ADDITIONAL INFO REGARDING PATIENT DEMOGRAPHICS AND SPECIFIC DETAILS ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PUMP CE ENGLISH VERSION NONE FRN BAXTER HEALTHCARE PTE. LTD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention