BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2072127 · Received April 28, 2011

    Report

    Report Number
    6000001-2011-03257
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS AN ONGOING CAPA INVESTIGATION, MDQ-CAPA-(B)(4) ASSOCIATED WITH THIS REPORT. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF 812:02 FAILURE CODE ON CHANNEL A. (B)(4)

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 812.02 WAS CONFIRMED AND DUPLICATED AND WAS FOUND TO BE DUE TO A FAULTY PUMP HEAD MODULE. THE PUMP HEAD MODULE ASSEMBLY CHANNEL A WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME 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 AN 812:02 FAILURE CODE ON CHANNEL A. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.04.00 WHICH IS CATEGORIZED AS UNREMEDIATED. DURING REVIEW OF THE EVENT HISTORY BY BAXTER IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY. 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