BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240201 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06147
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 11, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    2005-047-MD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: FAILURE CODE 804:54 WAS INITIALLY REPORTED BY THE FACILITY. IT IS UNKNOWN WHEN THE FAILURE CODE OCCURRED. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS REPLACED. ALTHOUGH THE REPORTED FAILURE CODE 804:54 WAS NOT CONFIRMED IN THE EVENT HISTORY OR REPRODUCED DURING EVALUATION, THE UIM PCB IS STILL REPORTABLE BECAUSE THE COMPONENT WAS REPLACED AS A RESULT OF THE CUSTOMER REPORTED FAILURE CODE 804:54. THIS FAILURE CODE IS USUALLY MANIFESTED AS A RESULT OF THE UIM PCB BEING DEFECTIVE.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS REPLACED AS A RESULT OF THE CUSTOMER REPORTED FAILURE CODE 804:54. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE..

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1