BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1230557 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88615
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 6, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DURING EVALUATION THE REPORTED CONDITION OF AIL PCB OUT OF SPECIFICATION WAS CONFIRMED. INSPECTION OF THE DEVICE REVEALED FAILURE CODE 810:11 IS CAUSED BY A DEFECTIVE AIL PCB. THE PUMP HEAD MODULE (PHM) WAS REPLACED ON THE PUMP TO CORRECT THE FAILURE.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO BAXTER FOR SERVICE. DURING THE EVALUATION, THE TECHNICIAN NOTED AN AIR IN LINE ERROR IN WHICH THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) WAS DETERMINED TO BE OUT OF SPECIFICATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1