BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1982998 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00811
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 11, 2010
    Report Date
    January 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN FORWARDED TO BAXTER PRODUCT ANALYSIS LAB. UPON COMPLETION OF BAXTER'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE REPORTED CONDITION OF FAILURE CODE 807:04 WAS CONFIRMED BUT NOT DUPLICATED DUE TO CORROSION FOUND ON THE CHANNEL A PUMP HEAD MODULE PRINTED CIRCUIT BOARD. THE CHANNEL A PUMP HEAD MODULE WAS REPLACED TO CORRECT THE REPORTED CONDITION. 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 (B)(4). THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF ?FC 807:04.? (B)(4).

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY IT WAS DISCOVERED THAT CHANNEL A FAILURE CODE 807:04 OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY. 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.

    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