BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1231420 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88365
    Event Type
    Injury
    Date Received
    November 17, 2008
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TRENDING DATA WAS REVIEWED FOR THE PERIOD OF 2005 TROUGH 2007, AND NO UNFAVORABLE TREND WAS OBSERVED. INITIAL EVALUATION OF THE PUMP IDENTIFIED THE ROOT CAUSE AS DEFECTIVE PUMP HEAD MECHANISM "B". FURTHER EVALUATION WAS CONDUCTED ON THE PUMP HEAD WHICH REVEALED A COMMUNICATION ERROR BETWEEN THE USER INTERFACE MODULE AND PUMP HEAD MODULE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURN TO BAXTER CANADA 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 FROM ANOTHER COUNTRY 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 THE PATIENT 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 PATIENT¿S PRESSURE FLUCTUATED , A BOLUS DOSE WAS GIVEN TO STABILIZE THE BLOOD PRESSURE. THE PATIENT¿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 INFUSION PUMP FRN BAXTER HEALTHCARE PTE.LTD 2M8163

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention