BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE

    MDR report key: 1221879 · Received November 4, 2008

    Report

    Report Number
    6000001-2008-00702
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    October 16, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT SEQUESTERED. THE EVENT HISTORY HAS BEEN OVERWRITTEN WITH NEW HISTORY DATA. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON OCTOBER 16, 2008, THE CUSTOMER NOTIFIED BAXTER THAT CONFUSION AND COMPLEXITY OF THE PROGRAMMING OF BOLUS (PIGGYBACK), WITH THE NEW D2 CXE TRIPLE CHANNEL COLLEAGUE VOLUMETRIC INFUSION PUMP, LEAD TO A MEDICATION ERROR. A FEMALE PATIENT WAS ADMITTED IN 2008 FOR ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) WITH SEPTIC SHOCK AND UROSEPSIS. THE PATIENT WAS UNDER SEDATION ON AN OSCILLATOR/VENTILATOR. LEVOPHED WAS INFUSING AT A CONCENTRATION OF 8MG/250ML AT A RATE OF 5ML/H THROUGH A CENTRAL LINE TO MAINTAIN THE SYSTOLIC PRESSURE TO 110MMHG. THE PATIENT WAS IN A PRE-CODE STATE. THE PATIENT'S PRESSURE DECREASED TO 90/50MMHG AND A 2ML BOLUS OF LEVOPHED WAS PRESCRIBED. THE COMMON PRACTICE IS TO GIVE THE BOLUS USING THE COLLEAGUE PIGGY BACK MODE RATE-VOLUME WHERE THE BOLUS IS PULLED FROM THE PRIMARY BAG THEN REVERTS TO ITS NORMAL PRIMARY INFUSION RATE AND VOLUME REMAINING. THE NURSE PRESSED STOP TO ACCESS THE CHANGE MODE FUNCTIONALITY IN ORDER TO GET TO THE PIGGYBACK RATE VOLUME OPTION. BY DOING SO, THE BLOOD PRESSURE DROPPED FROM 100MMHG TO 40/20MMHG. THE NURSE DID NOT HAVE TIME TO ACCESS THE CHANGE MODE SCREENS TO ACCESS THE PIGGYBACK FUNCTION SO SHE HAD TO OPEN THE PUMP CHANNEL AND MANUALLY TITRATE THE MEDICATION TO FLUSH THE LEVOPHED. FOLLOWING THE EVENT, THE SYSTOLIC PRESSURE WAS RESTORED TO 100MGHG BUT AT THE TIME OF THE EVENT STAFF HAD TO INCREASE THE PRIMARY RATE TO 50ML/HOUR. THE PATIENT WAS ALSO RECEIVING FENTANYL 10 MCG/ML AT 50ML/HOUR AND VERSED 1 MG/ML AT 5ML/HOUR. THREE OR FOUR COLLEAGUE CXE UPGRADED DEVICES WERE IN USE ON THE PATIENT AT THE TIME OF THE EVENT. THE PATIENT REMAINS UNDER SEDATION, WITH SLIGHT RESPIRATORY IMPROVEMENT, AND ON A CONVENTIONAL VENTILATOR. NO LABS OR SCANS WERE ORDERED AS A RESULT OF THE EVENT. SAME PATIENT WAS INVOLVED IN ANOTHER REPORTED INCIDENT WITH A COLLEAGUE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE 80FRN FRN BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention