BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1196661 · Received October 2, 2008

    Report

    Report Number
    6000001-2008-00593
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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, OF IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT IT IS UNK IF AN OVER-INFUSION OF POTASSIUM CHLORIDE INJECTION (HIGHLY CONCENTRATED POTASSIUM CHLORIDE FOR INJECTION. VIAFLEX PLASTIC CONTAINER, 10 MEQ/ 100 ML; PRODUCT CODE 2B0826, LOT NUMBER P221424) MIGHT HAVE OCCURRED OR IF THE SECONDARY PIGGY-BACK OF THE POTASSIUM CHLORIDE INJECTION BACKED UP INTO THE PRIMARY SOLUTION BAG (CONTAINING 5% DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION, USP. VIAFLEX PLASTIC CONTAINER, 1000ML; PRODUCT CODE 2B1074X, LOT NUMBER C747360) DURING INFUSION OF AN UNSPECIFIED PT. THE REPORTER STATED THAT THE PUMP WAS PROGRAMMED WITH THE PRIMARY RATE SET AT 80.0ML/HR FOR THE 1000ML PRIMARY BAG WITH THE SECONDARY POTASSIUM CHLORIDE AT A RATE OF 100ML/HR WITH VOLUME TO BE INFUSED AT 100MLS. THE REPORTER STATED THAT PER THE STAFF, ONLY 10 MINUTES HAD ELAPSED AFTER STARTING THE INFUSION BEFORE IT WAS DISCOVERED THAT THE PIGGYBACK OF POTASSIUM CHLORIDE WAS EMPTY, BUT THE PUMP INDICATED THAT ONLY 17ML. HAD BEEN DELIVERED. THE REPORTER STATED THAT THE PRIMARY BAG STILL HAD 713ML TO BE INFUSED. THE REPORTER STATED THAT THE PT IS FINE AND THERE WERE NO ADVERSE EVENTS AND THAT SHE DOES NOT KNOW IF LABS WERE DRAWN FOR THE PT, BUT THAT IT WAS MENTIONED TO HER THAN AN INTERNAL INCIDENT REPORT WOULD BE INITIATED. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1