BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1210174 · Received October 20, 2008

    Report

    Report Number
    6000001-2008-00640
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED LITHIUM BATTERY PROBLEM WAS CONFIRMED AS A LOW LITHIUM BATTERY ALERT DURING PUMP POWER ON. THE CAUSE OF THE LOW LITHIUM BATTERY WAS NOT DETERMINED BECAUSE THE CUSTOMER REFUSED THE REPAIR ESTIMATE AND REQUESTED THAT THE PUMP BE RETURNED UNREPAIRED.

    Description of Event or Problem · 1

    THE FACILITY INITIALLY REPORTED AN INFUSION PUMP WITH A LITHIUM BATTERY PROBLEM THAT OCCURRED DURING PATIENT USE IN 2008. ADDITIONAL INFORMATION WAS OBTAINED BY BAXTER TWO MONTHS LATER, INDICATING THAT THE EVENT OCCURRED DURING PATIENT INFUSION AND RESULTED IN THE INTERRUPTION OF PATIENT INFUSION. THE PUMP WAS SWAPPED FOR ANOTHER ONE IN ORDER TO CONTINUE INFUSION. 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 3CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1