BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1982941 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00795
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH LOW BATTERY WAS CONFIRMED DURING PRODUCT EVALUATION BY BAXTER QUALITY ENGINEERING. IT WAS DETERMINED BY BAXTER QUALITY ENGINEERING THAT THE REPORTED CONDITION WAS RELATED TO FAILURE CODE 814:01 WHICH WAS CAUSED BY THE DEPLETION OF THE MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE THEREFORE REPLACED TO RESOLVE THIS ISSUE. REVIEW OF THE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION OCCURRED ON (B)(6) 2010 NOT ON THE REPORTED OCCURRENCE DATE OF (B)(6) 2010. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED THE DEVICE HAS BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. 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).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED A LOW BATTERY. IT IS UNKNOWN WHICH PROCESS STEP THIS EVENT OCCURRED DURING. ENGINEERING REVIEW OF THE DEVICE EVENT HISTORY CONFIRMED THIS CONDITION. IT WAS DETERMINED BY BAXTER QUALITY ENGINEERING THAT THE REPORTED CONDITION IS RELATED TO FAILURE CODE 814:01, WHICH INTERRUPTED DELIVERY. THERE WAS NO PATIENT INVOLVEMENT, AND THEREFORE NO PATIENT INJURY OR MEDICAL INTERVENTION. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00. 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