BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1022993 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-02813
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    August 30, 2006
    Report Date
    August 30, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONDITION OF FAIL CODE 812:02 WAS OBSERVED IN THE EVENT HISTORY DURING PRODUCT EVALUATION. THE FAIL CODE WAS NOT DUPLICATED AND THE ROOT CAUSE WAS UNKNOWN. THE DEVICE WAS SENT TO REFURBISHMENT.

    Description of Event or Problem · 1

    THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING SERVICE THE BAXTER REPAIR TECHNICIAN NOTED FAIL CODE 812:02 IN THE EVENT HISTORY OF CHANNEL A. THE HOSPITAL REPRESENTATIVE STATED THAT THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1