BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1982263 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00753
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    June 7, 2010
    Report Date
    August 10, 2010
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE CHANNEL B FAILURE CODE 808:02 WAS CONFIRMED BUT NOT DUPLICATED. THE REPORTED CONDITION WAS DUE TO A FAULTY CHANNEL B PUMP HEAD MODULE. THE CHANNEL B PUMP HEAD MODULE WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A CHANNEL B FAILURE CODE 808:02. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. 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. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.04.00 CATEGORIZED AS UNREMEDIATED.

    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