BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2073286 · Received May 1, 2011

    Report

    Report Number
    6000001-2011-03311
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    October 26, 2010
    Report Date
    April 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INFORMATION WAS INADVERTENTLY INCORRECT IN INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF PUMP 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).

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER IT WAS DETERMINED THAT FAILURE CODE 810:11 OCCURRED ON (B)(6) 2010 DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. 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 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1