BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1827296 · Received September 7, 2010

    Report

    Report Number
    6000001-2010-03055
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS AN ONGOING CAPA INVESTIGATION, MDQ-CAPA-(B)(4) ASSOCIATED WITH THIS REPORT. (B)(4)

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 808:02 WAS CONFIRMED BUT NOT DUPLICATED. THE REPORTED CONDITION IS DUE TO A FAULTY PHM (PUMP HEAD MODULE). THIS DEVICE WILL NOT BE RETURNING TO THE CUSTOMER , THEREFORE NO REPAIRS WILL BE MADE. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 808:02. THE REPORTED CONDITION WAS IDENTIFIED DURING BIOMEDICAL TESTING. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION RELATED TO THE REPORTED CONDITION. THE PUMP WAS CATEGORIZED AS A COLLEAGUE 2006 PUMP WITH SOFTWARE VERSION 5.09.90. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING BAXTER QUALITY ENGINEERING REVIEW OF THE EVENT HISTORY ON (B)(4), 2010, IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1