BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1021538 · Received March 26, 2008

    Report

    Report Number
    6000001-2008-00191
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 28, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE REPORTED CONDITION OF A PUMP THAT WILL RUN FOR 5 MINS AND THEN TURNS OFF WAS NOT CONFIRMED DURING PROD EVAL. THEREFORE, NO FURTHER CORRECTION WAS MADE CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP THAT WILL RUN FOR 5 MINS AND THEN TURN OFF. IT IS UNK WHEN THIS EVENT OCCURRED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1