BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 2000921 · Received February 24, 2011

    Report

    Report Number
    6000001-2011-01329
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    July 1, 2010
    Report Date
    January 31, 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). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 808:06 WAS CONFIRMED DURING A REVIEW OF THE PUMP'S EVENT HISTORY. THE ASSIGNABLE CAUSE OF THIS CONDITION WAS DETERMINED TO BE A DEFECTIVE PUMP HEAD MODULE (PHM). THE PUMPHEAD MODULE WAS REPLACED TO CORRECT THIS CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    UPON EVENT HISTORY REVIEW CONDUCTED BY BAXTER QUALITY ENGINEER THIS DEVICE WAS FOUND TO HAVE EXPERIENCED AN 808:06 FAILURE CODE. THE REPORTED CONDITION OCCURRED DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. 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. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED.

    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