BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1200434 · Received October 20, 2008

    Report

    Report Number
    6000001-2007-01942
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 22, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH INSTRUCTION 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 18, 2007. EVALUATION SUMMARY:THE REPORTED CONDITION OF FAIL CODE 812:02 WAS NOT CONFIRMED OR DUPLICATED DURING PRODUCT EVALUATION. NO ACTION WAS NECESSARY FOR THIS FAIL CODE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSION PUMP WITH FAILURE CODE 812:02. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE FAILURE OCCURRED DURING A PATIENT INFUSION. 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 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1