BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1813521 · Received August 24, 2010

    Report

    Report Number
    6000001-2010-02731
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE INVESTIGATION FOR THE REPORTED PROBLEM IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 814:04 WAS CONFIRMED BUT NOT DUPLICATED. THE REPORTED CONDITION IS CAUSED BY A FAULTY PHM (PUMP HEAD MODULE). THE PHM WAS REPLACED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE PUMP WITH FAILURE CODE 814:04. THE REPORTED CONDITION OCCURRED DURING BIOMED TESTING. DURING BAXTER'S REVIEW OF THE DEVICE EVENT HISTORY, IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1