BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1943129 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06513
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. THE ROOT CAUSE WAS DETERMINED TO BE A FAULTY CHANNEL A PHM (PUMP HEAD MODULE). THE CHANNEL A PHM WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A CONDITION OF "CHANNEL A INOPERATIVE" (UNKNOWN FAILURE CODE). THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PROGRAMMING/SET-UP. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. DURING REVIEW OF THE EVENT HISTORY BY BAXTER, THE REPORTED PROBLEM WAS CONFIRMED AS A FAILURE CODE 807:05 WHICH CAUSED AN INTERRUPTION OF DELIVERY. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.04.00 WHICH IS CATEGORIZED AS UNREMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1