BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1426500 · Received July 31, 2009

    Report

    Report Number
    6000001-2009-00762
    Event Type
    Malfunction
    Date Received
    July 31, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 2, 2009
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE CONDITION OF COLLEAGUE PUMP IN WHICH THE STOP KEY ON THE PHM KEYPAD WAS INOPERABLE WAS CONFIRMED AND DUPLICATED DURING PRODUCT EVAL. THE ASSIGNABLE CAUSE WAS NOT IDENTIFIED IN THE EVAL; HOWEVER, THE PHM KEYPAD WAS REPLACED TO FIX THE REPORTED CONDITION. THE PUMP WAS TESTED PER PROCEDURE AND RETURNED TO THE FACILITY WITHIN SPECIFICATION. THIS ISSUE IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE COLLEAGUE PUMP WAS RETURNED TO BAXTER FOR SERVICE ON A DAMAGED PUMP HEAD MODULE (PHM) KEYPAD. DURING TESTING, THE BAXTER TECH REPORTED THAT THE STOP BUTTON ON THE PHM KEYPAD WAS INOPERABLE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1