BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 875285 · Received June 12, 2007

    Report

    Report Number
    6000001-2007-00365
    Event Type
    Injury
    Date Received
    June 12, 2007
    Date of Event
    May 25, 2007
    Report Date
    June 1, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Removal / Correction Number
    2006-0028-MD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO BAXTER TECHNICAL SERVICES FOR EVALUATION. THE DEVICE WAS REPAIRED ON-SITE. THE CAUSE OF THE FAIL CODE WAS DUE TO A DEFECTIVE PUMP-HEAD MODULE. THE PUMP-HEAD MODULE WAS REPLACED.

    Description of Event or Problem · 1

    INTERNATIONAL COMPLAINT RECEIVED COMPLAINT COORDINATOR. THE FACILITY REPORTED THAT THEY ENCOUNTERED FAIL CODE 804:29 ON CHANNEL "B" ON THEIR COLLEAGUE VOLUMETRIC INFUSION PUMP. THE CUSTOMER REPORTED THAT THE INCIDENT OCCURRED DURING A BLOOD PRESSURE STABILIZATION MANEUVER AND THAT THE PT REQUIRED MEDICAL INTERVENTION TO AVOID INJURY DUE TO THE SUDDEN STOPPING OF THE INFUSION. THE PUMP WAS INFUSING LEVOPHED ON A TRIPLE CHANNEL ON LINE "B". WHEN THE PUMP FAILED THE PT'S PRESSURE FLUCTUATED, A BOLUS DOSE WAS GIVEN TO THE PT TO STABILIZE THE BLOOD PRESSURE. THE PT'S PRESSURE RETURNED IMMEDIATELY TO A NORMAL RANGE AND NO OTHER EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD 2M8163

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention