BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXTER COLLEAGUE 3 CX PUMP

    MDR report key: 1812366 · Received August 13, 2010

    Report

    Report Number
    MW5017171
    Event Type
    Other
    Date Received
    August 13, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 14, 2010
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, A BAXTER COLLEAGUE 3 CX PUMP WAS BEING USED TO ADMINISTER A PRIMARY INTRAVENOUS SOLUTION OF LR AT 200ML/HR. AT APPROXIMATELY 2100, THE NURSE PROGRAMMED THE PUMP TO ADMINISTER A PIGGYBACK INFUSION OF ANTIBIOTIC AT 200ML/HR. AT APPROXIMATELY 2130, THE PT NOTED THAT THE PUMP BEGAN MAKING A "FUNNY SOUND - LIKE RUNNING WATER". SHE CALLED THE NURSE INTO THE ROOM, WHO FOUND THAT THE PRIMARY RATE WAS NOW 999ML/HR. THE PT AND VISITOR IN THE ROOM STATED THAT NEITHER HAD TAMPERED WITH THE PUMP. THE PUMP WAS TURNED OFF, REPLACED WITH ANOTHER PUMP, AND THE INTRAVENOUS SOLUTION CONTINUED AT 200ML/HR. THE PUMP WAS IMMEDIATELY REMOVED FROM SERVICE AND LOCK-OUT TAGGED. OUR BIOMEDICAL ENGINEERING DEPT REVIEWED THE PUMP HISTORY ON (B)(6) 2010. THE HISTORY CONFIRMED THAT BOTH THE PRIMARY AND THE SECONDARY RATES HAD BEEN SET AT 200ML/HR, BUT WHEN THE SECONDARY INFUSION WAS COMPLETED, THE PUMP RATE SPONTANEOUSLY JUMPED TO 999ML/HR. THIS MALFUNCTION RESULTED IN NO NEGATIVE PT OUTCOME. HOWEVER, HAD THE PUMP BEEN IN USE ON A SLEEPING OR DISORIENTED PT, OR HAD THE PRIMARY INFUSION CONTAINED A MEDICATION, THE OUTCOME MAY HAVE BEEN DIFFERENT. THE MALFUNCTION WAS REPORTED BY BAXTER ON (B)(6) 2010 BY BIOMEDICAL ENGINEERING DEPT OF THIS FACILITY. THE PUMP REMAINS OUT OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER COLLEAGUE 3 CX PUMP NONE FRN

    Patients

    Seq Age Sex Outcome Treatment
    1