BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XL3 PUMP

    MDR report key: 670632 · Received January 31, 2006

    Report

    Report Number
    2921482-2006-00734
    Event Type
    Malfunction
    Date Received
    January 31, 2006
    Date of Event
    January 2, 2006
    Report Date
    January 4, 2006
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE RATE INDEPENDENTLY CHANGED RESULTING IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. CANNEL B OF THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF XIGRIS AT A RATE OF 12ML/HR WITH A VOLUME TO BE INFUSED (VTBI) OF 100ML AND THE DELIVERY WAS STARTED. APPROXIMATELY ONE HOUR LATER, THE PUMP ALARMED VTBI COMPLETE AND THE NURSE NOTED THAT THE ENTIRE BAG OF XIGRIS WAS EMPTY. REPORTEDLY, CHANNEL B DISPLAYED A RATE OF 84L/HR. THE NURSE REPROGRAMMED CHANNEL B TO DELIVER AT A RATE OF 12ML/HR AND THE DELIVERY OF XIGRIS WAS RESUMED. THE NEXT DAY, AT AN UNSPECIFIED TIME, THE PUMP WAS REMOVED FROM CLINICAL SERVICE AND THE THERAPY WAS RESUMED USING A REPLACEMENT PUMP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE BIOMEDICAL ENGINEER PROGRAMMED CHANNEL B TO DELIVER AT A RATE OF 20ML/HR WITH A VTBI OF 200ML. AFTER THE CONTROL KNOB WAS TURNED TO THE RUN POSITION, THE BIOMEDICAL ENGINEER NOTED CHANNEL B DISPLAYED A RATE OF 200ML/HR. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XL3 PUMP INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other