BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1023088 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00700
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 29, 2006
    Report Date
    December 29, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILURE CODE 810:11 ON CHANNEL A WAS CONFIRMED IN THE PUMP'S EVENT HISTORY FILE DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE FOUND THAT FAILURE CODE 810:11 WAS CAUSED BY A DIRTY PUMP HEAD MECHANISM CHANNEL A. THE PUMP HEAD MECHANISUM CHANNEL WAS CLEANED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, FAILURE CODE 810:11 WAS IDENTIFIED IN THE PUMP'S EVENT HISTORY FILE ON CHANNEL A. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1