BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1073689 · Received July 3, 2008

    Report

    Report Number
    6000001-2008-00414
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 20, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVAL, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT SHE HAD STARTED A PIGGY BACK INFUSION ON A FEMALE AS A TREATMENT, 2008. THE PIGGY BACK WAS A 250 ML BAG OF HOSPIRA VANCOMYCIN WITH LOT #64-063-JT THAT WAS SET TO INFUSE AT 150 ML PER HOUR. THE PRIMARY WAS A 1000 ML BAG OF B. BRAUN POTASSIUM CHLORIDE WITH LOT# J8C584 THAT WAS SET TO INFUSE AT 150 ML PER HOUR. WHEN NURSE RETURNED TO ROOM THE COLLEAGUE TRIPLE CHANNEL INFUSION PUMP, 2M8163, READ THAT THERE WAS 188 ML LEFT IN THE PIGGY BACK BAG OF VANCOMYCIN AND WHEN SHE LOOKED, THE PIGGY BACK BAG WAS EMPTY. THUS STATING THAT THIS WAS AN OVER-INFUSION. THE NURSE HAS FILED AN OCCURRENCE REPORT ON THIS INCIDENT. THE NURSE ALSO STATED THAT THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY ON THIS SERVICE EVENT. NO ADDITIONAL INFO 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