BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1201206 · Received October 20, 2008

    Report

    Report Number
    6000001-2007-00514
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 8, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 05, 2007. EVALUATION SUMMARY:THE CONDITION OF FAIL CODE 812:02 WAS CONFIRMED. A CHANNEL A PUMP HEAD MODULE CAM SHAFT CAUSED THIS FAIL CODE. THE CHANNEL A PUMP HEAD MODULE WAS REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED FAILURE CODE 812:02 ON CHANNEL A. THE EVENT OCCURRED DURING BIO-MED TESTING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. 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