BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1358730 · Received April 8, 2009

    Report

    Report Number
    6000001-2009-00325
    Event Type
    Malfunction
    Date Received
    April 8, 2009
    Date of Event
    March 19, 2009
    Report Date
    March 23, 2009
    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 PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP THAT DISPLAYED FAILURE CODE 302:435:118:0007 DURING PATIENT INFUSION. THE PUMP ALARMED AND THEN FAILED TO INFUSE AS INTENDED. A FEMALE WAS BEING INFUSED WITH AN UNKNOWN CONCENTRATION OF LEVOPHED AND NITROGLYCERIN. THE FACILITY HAD DOCUMENTED THAT THERE WAS SOME TEMPORARY HARM TO THE PATIENT THAT REQUIRED TREATMENT AS A RESULT OF THE SHUTDOWN. HOWEVER, IT WAS NOT DOCUMENTED WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DOCUMENTED AS DOING WELL, AND THAT THERE IS NO FURTHER INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1