BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1250770 · Received December 2, 2008

    Report

    Report Number
    6000001-2008-00815
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF AN INFUSION PUMP WITH A NON-WORKING CHANNEL A WAS CONFIRMED DURING EVALUATION. THE REPORTED CONDITION WAS ATTRIBUTED TO AN INOPERATIVE PUMP HEAD MODULE KEYPAD ON CHANNEL A. THE KEYPAD WAS REPLACED TO FIX THE PROBLEM AND THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A NON-WORKING CHANNEL A. THE EVENT WAS REPORTED TO HAVE OCCURRED PRIOR TO USE. 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 3 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1