BEUDAMED
    FDA Adverse Event Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 2081147 · Received April 27, 2011

    Report

    Report Number
    2081147
    Date Received
    April 27, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE WERE INVESTIGATING THE POSSIBILITY OF TUBING MISCONNECTIONS WITH CLINICAL STAFF AND FOUND THAT IT IS PHYSICALLY POSSIBLE FOR A MAINLINE IV SET (SMARTSITE INFUSION SET FROM CAREFUSION, REF# 2426-0500) TO BE DIRECTLY CONNECTED TO THE EPIDURAL CATHETERS LISTED ABOVE. WHILE NO EVENT ACTUALLY OCCURRED, WE ARE CONCERNED THAT THERE IS NO PHYSICAL INCOMPATABILITY. IT IS POSSIBLE THAT A PHYSICIAN OR NURSE COULD CONNECT A PATIENT'S IV LINE DIRECTLY TO A CATHETER SITTING IN THE EPIDURAL SPACE. THE MALE TO FEMALE LEUR CONNECTIONS ON THE IV LINE AND THE EPIDURAL CATHETERS ARE COMPATABLE, MAKING IT POSSIBLE FOR THE CONNECTION TO OCCUR.======================MANUFACTURER RESPONSE FOR PRIMARY IV TUBING, SMARTSITE INFUSION SET (PER SITE REPORTER)======================WE HAVE NOTIFIED THE MANUFACTURER AND ARE AWAITING THEIR RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE INFUSION SET INTRAVASCULAR TUBING FPA CAREFUSION 2426-0500 *
    2 EPIDURAL CATHETERIZATION KIT EPIDURAL ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC (TELEFLEX MEDICAL) * *
    3 PERIFIX EPIDURAL CATHETER BSO B BRAUN MEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *