BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B BRAUN SPACE PUMP

    MDR report key: 2472550 · Received February 17, 2012

    Report

    Report Number
    2472550
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 17, 2012
    Manufacturer
    B BRAUN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ON WEIGHT-BASED INFUSION OF PROPOFOL. RATE ADJUSTED SEVERAL TIMES DURING COURSE OF INFUSION (+/- 3ML PER HR). ACCORDING TO THE NURSE, PATIENT TRANSPORTED FOR CT AND INITIALLY DURING CT PROCEDURE THE PUMP APPEARED TO BE INFUSING AT AN APPROPRIATE RATE. THEN SUDDENLY THE PROPOFOL BEGAN TO BUBBLE AND THE LEVEL DROPPED RAPIDLY IN THE BOTTLE. THE PUMP WAS IMMEDIATELY TURNED OFF, BUT MOST OF THE CONTENTS OF THE BOTTLE HAD INFUSED INTO THE PATIENT. SINCE THE PATIENT WAS ON A VENTILATOR AT THE TIME, THERE WAS NO HARM TO THE PATIENT. PUMP HISTORY INDICATES PROGRAMMING WAS PERFORMED CORRECTLY BY THE NURSE. THE PUMP FAILED TO RECORD THE ACTUAL AMOUNT OF PROPOFOL THAT INFUSED. THE FREE-FLOW CLIP WAS INSPECTED AND FOUND TO BE INTACT. THE CAUSE OF THE FREE-FLOW EVENT IS CURRENTLY UNDER INVESTIGATION. SIMILAR EVENTS HAVE BEEN REPORTED AT OTHER FACILITIES WITHIN OUR HOSPITAL NETWORK, BUT THIS IS THE FIRST SUCH EVENT AT OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B BRAUN SPACE PUMP INFUSION PUMP FRN B BRAUN 686G030103 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR