BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV STAR

    MDR report key: 2081221 · Received April 29, 2011

    Report

    Report Number
    2081221
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 29, 2011
    Manufacturer
    CODAN
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A CANCER DIAGNOSIS IS RECEIVING CHEMOTHERAPY AS AN OUTPATIENT. CHEMOTHERAPY IV FLUOROURACIL (5FU) INFUSION WAS ATTACHED USING (B)(4) EXTENSION TUBING SET WITH .22 MICRON FILTER TO GEMSTAR AMBULATORY PUMP TUBING. PATIENT IDENTIFIED WHILE IN HOME SETTING THAT CHEMOTHERAPY WAS LEAKING AT LOCATION OF FILTER. ALSO NOTED THE PUMP AND BAG WAS SATURATED WITH FLUID. PATIENT STATED THAT HE CLAMPED THE TUBING, WASHED HIS HANDS, AND RETURNED TO THE OUTPATIENT CENTER. INFUSION PUMP SHOWED 23.9ML OF 5FU HAD INFUSED. PHYSICIAN INFORMED; NEW BAG OF CHEMOTHERAPY PREPARED AND ATTACHED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV STAR INTRAVASCULAR TUBING FPA CODAN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR CHEMOTHERAPY