BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1392200 · Received May 20, 2009

    Report

    Report Number
    6000001-2009-00446
    Event Type
    Injury
    Date Received
    May 20, 2009
    Date of Event
    May 12, 2009
    Report Date
    May 13, 2009
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REFUSES TO SEND THE DEVICE IN FOR EVALUATION SINCE THEY BELIEVE THAT THERE WAS A MISPROGRAMMING ISSUE. A COPY OF THE PUMP EVENT HISTORY WAS PROVIDED AND IS BEING REVIEWED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE PUMP EVENT HISTORY REVIEW OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN OVERDELIVERY OF HEPARIN, LOT NUMBER P232181, INVOLVING A COLLEAGUE SINGLE CHANNEL PUMP. THE HEPARIN WAS SUPPOSED TO BE INFUSED OVER EIGHT HOURS, BUT WAS COMPLETELY INFUSED WITHIN 90 MINUTES. THE RATE AND DOSAGE ARE UNKNOWN, HOWEVER, THE BIOMEDICAL ENGINEER WHO DOWNLOADED THE EVENT HISTORY BELIEVES THAT THE RATE WAS SET FOR 800ML/HR AT THE TIME OF THE INCIDENT. THE BIOMEDICAL ENGINEER SPECULATES THAT THE RATE OF THE INFUSION SHOULD HAVE BEEN SET AT 8ML/HR. THE PATIENT WAS GIVEN PROTAMINE SULFATE BY PHYSICIAN'S ORDER. COAGULATION STUDIES WERE CONDUCTED SEVERAL TIMES. THE RESULTS WERE NOT PROVIDED. THE PATIENT CONTINUED TO BE MONITORED AND IS DOING WELL AT THIS POINT. THE PATIENT'S HEPARIN LEVEL IS WITHIN THERAPEUTIC RANGE. THE SOFTWARE VERSION FOR THIS PUMP IS 6.13.90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP 80FRN FRN BAXTER HEALTHCARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE PATIENT WAS GIVEN PROTAMINE SULFATE TO| COUNTERACT HEPARIN OVERDOSE.