BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1073688 · Received July 3, 2008

    Report

    Report Number
    6000001-2008-00413
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE REC'D FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO PRODUCT SURVEILLANCE A PUMP THAT FAILED TO ALARM. THE FACILITY WAS INFUSING A CHEMO THERAPY PATIENT WITH A 400ML OF SALINE SOLUTION AFTER THE CHEMO THERAPY. AT THE END OF THE INFUSION, AS THE BAG EMPTIED, AIR WAS PULLED INTO THE TUBING, THAT AIR WAS IN THE LINE. THE AIR WENT FROM THE IV BAG TO THE DEVICE. THE DEVICE FAILED TO ALARM. THE NURSE SAW THE AIR IN LINE AND DISCONTINUED THERAPY. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REQUIRED. THIS PROBLEM WAS IDENTIFIED DURING PT USE. 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 CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1