BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY TUBING SET

    MDR report key: 3897003 · Received May 16, 2014

    Report

    Report Number
    9616066-2014-00463
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED "SECONDARY INFUSION FLOWED INTO PRIMARY BAG AND THIS WAS VISUALIZED IMMEDIATELY AFTER THE SECONDARY INFUSION WAS STARTED." THERE WAS NO REPORT OF HARM TO PATIENT OR MEDICAL INTERVENTION. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294571 PRIMARY TUBING SET UNK FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY TUBING, MANUFACTURER/MODEL/LOT: UNK