BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1914587 · Received December 3, 2010

    Report

    Report Number
    6000001-2010-05453
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILURE CODE 810:11 WAS CONFIRMED THROUGH THE EVENT HISTORY, BUT COULD NOT BE DUPLICATED. AN AIR IN LINE TEST WAS PERFORMED. THE PUMP PASSED THE TEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    THERE IS AN ONGOING CAPA INVESTIGATION, MDQ-CAPA-(B)(4) ASSOCIATED WITH THIS REPORT. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF 'FC 810:11'. (B)(4)

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY BY BAXTER A FAILURE CODE 810:11WAS FOUND TO HAVE INTERRUPTED THERAPY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1