BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1840549 · Received September 21, 2010

    Report

    Report Number
    6000001-2010-03407
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ROOT CAUSE INVESTIGATION FOR THE REPORTED PROBLEM IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 808:02 WAS CONFIRMED BUT NOT DUPLICATED. THE REPORTED CONDITION IS DUE TO A FAULTY PHM (PUMP HEAD MODULE). THIS DEVICE WILL NOT BE REPAIRED OR BE RETURNED TO THE CUSTOMER AND WILL REMAIN AT BAXTER. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 808:02. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING BIOMED SERVICING. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 THAT IS CATEGORIZED AS A REMEDIATED "COLLEAGUE (B)(4)" PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING BAXTER QUALITY ENGINEERING REVIEW OF THE EVENT HISTORY ON (B)(6) 2010, IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING 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