BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1230295 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88549
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 8, 2007
    Report Date
    June 8, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF A FAILED ACCURACY TEST FOR OVERINFUSION WAS CONFIRMED DURING PRODUCT EVALUATION. THIS EVENT WAS CAUSED BY A FAULTY PUMP HEAD MECHANISM. THE PUMP HEAD MECHANISM WAS REPLACED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP THAT FAILED AN ACCURACY TEST FOR OVERINFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION 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. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1