BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 716607 · Received November 16, 2005

    Report

    Report Number
    6000001-2005-06585
    Event Type
    Malfunction
    Date Received
    November 16, 2005
    Date of Event
    October 1, 2005
    Report Date
    October 21, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-2/25/05-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 570:320:840:0000. THE FAILURE CODE OCCURRED DURING BIO-MED TESTING. THERE WAS NO PT INJURY OIR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSP REP. NO ADDTIONAL CONTACT INFORMATION IS VAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA