BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1212702 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-81008
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 29, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 26, 2007. THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN TO THE REPORTE AT THIS TIME.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP THAT TURNS ITSELF ON AND OFF (UNINTENDED SHUTDOWN). IT IS UNKNOWN WHEN THE EVENET OCCURED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1