BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1864262 · Received October 12, 2010

    Report

    Report Number
    6000001-2010-03964
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF CHANNELS ARE OUT OF SERVICE WAS CONFIRMED AND DUPLICATED. THE REPORTED CONDITION IS DUE TO FAILURE CODE 803:20 ON CHANNEL B CAUSED BY CORROSION. CHANNEL A WAS REPLACED TO CORRECT THE REPORTED CONDITION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).CORRECTION: CHANNEL B WAS REPLACED TO RESOLVE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL INFORMATION: THE ROOT CAUSE INVESTIGATION FOR THE REPORTED PROBLEM IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF "CHANNELS ARE OUT OF SERVICE". IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.03.00 WHICH IS CATEGORIZED AS UNREMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING REVIEW OF THE EVENT HISTORY IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1