BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1233364 · Received November 19, 2008

    Report

    Report Number
    6000001-2007-03871
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH CONSTANT ALARMS. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. THE HOSPITAL REPRESENTATIVE STATED THEY HAVE NO RECORD OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT¿S DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING. NO ADDITIONAL CONTACT INFORMATION WAS AVAILABLE. THE PUMP WAS EVALUATED AND FOUND THAT THE PUMP STARTED ALARMING DEPLETED BATTERY AFTER PASSED SELF-TEST. FAILURE 570 WAS FOUND IN THE EVENT HISTORY THAT COULD CAUSED BY DEPLETED MAIN BATTERIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1