BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1864261 · Received October 12, 2010

    Report

    Report Number
    6000001-2010-03963
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 24, 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
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 810:11 WAS CONFIRMED BUT NOT DUPLICATED. THE ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME SINCE THIS IS A BAXTER OWNED DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4)

    Additional Manufacturer Narrative · 1

    THERE IS AN ONGOING CAPA INVESTIGATION, MDQ-CAPA-(B)(4) ASSOCIATED WITH THIS REPORT. (B)(4)

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 810:11. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING BIOMED SERVICING. IT IS UNKNOWN IF THERE WAS PATIENT INJURY OR MEDICAL INTERVENTION RELATED TO THE DEVICE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING REVIEW OF THE EVENT HISTORY IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1