BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC IFUSION PUMP

    MDR report key: 1415231 · Received July 14, 2009

    Report

    Report Number
    6000001-2009-00662
    Event Type
    Malfunction
    Date Received
    July 14, 2009
    Date of Event
    June 12, 2009
    Report Date
    June 12, 2009
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION SUMMARY: THE REPORTED CONDITION OF "CHANNEL B AND C DO NOT WORK" WAS CONFIRMED DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE REVEALED THE CONDITION WAS CAUSED BY A DEFECTIVE PUMP HEAD MODULE (PHM) KEYPAD ON CHANNEL B AND C. TO CORRECT THIS CONDITION, THE PHM KEYPAD WAS REPLACED ON CHANNEL B AND C. THE PUMP WAS RETESTED AND RETURNED TO THE CUSTOMER WITHIN SPECIFICATION. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA-(B) (4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A MALFUNCTION OF CHANNEL B AND C DO NOT WORK. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING BIOMED TESTING. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. THIS IS INVOLVING A PUMP WITH SOFTWARE (B) (4) WHICH IS CATEGORIZED AS UNREMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC IFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1