BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240232 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06173
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    2005-047-MD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILURE CODE 703 WAS CONFIRMED IN THE PUMP'S EVENT HISTORY FILE DURING PRODUCT EVALUATION. DURING PRODUCT EVALUATION, A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS OBSERVED. THE REPORTED CONDITION OF FAILURE CODE 703 CONFIRMS THE DEFECTIVE UIM PCB. THE UIM PCB WAS REPLACED AND THE DEVICE WAS TESTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 703. THIS PROBLEM WAS IDENTIFIED AFTER USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1