BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 3897019 · Received May 16, 2014

    Report

    Report Number
    9616066-2014-00474
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K801614
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT INFO REQUESTED AND ALL AVAILABLE INFO WAS INCLUDED IN SECTIONS A AND B. THIS REPORT WAS FILED BY THE MFR. CUSTOMER REPORTED THAT THE SET WAS NOT SAVED. THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE SET WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK DURING AN ETOPOSIDE INFUSION. THE LEAK OCCURRED AT THE FILTER. THE PT WAS ON THE ONCOLOGY FLOOR RECEIVING HIGH DOSE ETOPOSIDE (528 MG) RATE UNK. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294533 SMARTSITE EXTENSION SET FPA CAREFUSION CORP 20028E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL 2426-0007, LOT UNK| ALARIS PUMP MODULE ADMINISTRATION SET,