BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1040660 · Received May 9, 2008

    Report

    Report Number
    6000001-2008-00313
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE REPORTED CONDITION OF A PUMP THAT OVER INFUSED WAS NOT CONFIRMED NOR REPRODUCED DURING PRODUCT EVAL. THEREFORE, NO FURTHER ACTION WAS DEEMED NECESSARY. THE PUMP WAS TESTED AND RETURNED WITHIN SPECS.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP THAT WAS PROGRAMMED TO DELIVER 100ML OF AN UNK ANTIBIOTIC WITHIN A SPECIFIED AMOUNT OF TIME. THE BAG WAS EMPTY EVEN THOUGH THE PUMP STILL READ 37ML REMAINED FOR INFUSION. THUS RESULTING IN AN OVER INFUSION. IT IS UNK WHEN THIS EVENT OCCURRED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL 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