BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1862047 · Received October 8, 2010

    Report

    Report Number
    6000001-2010-03865
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF 812.04 WAS NOT CONFIRMED OR DUPLICATED HOWEVER FAILURE CODE 812:02 WAS CONFIRMED THROUGH THE EVENT HISTORY. FAILURE 812:02 IS DUE TO A FAULTY PHM (PUMP HEAD MODULE). THE PHM WAS REPLACED TO CORRECT THE REPORTED CONDITION. (B)(4)

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE PUMP WITH FAILURE CODE 812.04 CHANNEL A . IT WAS NOT SPECIFIED WHEN REPORTED CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.03.00 CATEGORIZED AS UNREMEDIATED. THE REPORTED CONDITION OF FAILURE CODE 812:04 WAS NOT FOUND, HOWEVER FAILURE CODE 812:02 WAS FOUND IN THE EVENT HISTORY. DURING REVIEW OF THE EVENT HISTORY IT WAS DETERMINED THAT FAILURE CODE 812:02 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