BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSOR PUMP-SINGLE CHANNEL

    MDR report key: 1844396 · Received September 24, 2010

    Report

    Report Number
    6000001-2010-03527
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF OCCLUSION PROBLEM WAS CONFIRMED BUT NOT DUPLICATED. THE REPORTED CONDITION IS DUE TO A FAULTY PUMP HEAD MODULE ASSEMBLY CAUSED DOWNSTREAM OCCLUSION PROBLEM. THE PUMP HEAD MODULE ASSEMBLY WAS REPLACED TO CORRECT THE REPORTED CONDITION. (B)(4).

    Description of Event or Problem · 1

    THE BAXTER'S FIELD SERVICE ENGINEER REPORTED A COLLEAGUE INFUSION PUMP WITH AN OCCLUSION PROBLEM. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    THIS CONDITION MAY HAVE BEEN A FALSE OCCLUSION ALARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1