BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® EXTENSION SET

    MDR report key: 6195290 · Received December 21, 2016

    Report

    Report Number
    9616066-2016-01820
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    December 2, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER¿S COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT SEQUESTERED AND WILL NOT BE RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING AT THE CONNECTION OF TWO IV SETS DURING AN UNSPECIFIED INFUSION WITHOUT FURTHER DETAILS. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED; THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843780 ALARIS® EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 30914

    Patients

    Seq Age Sex Outcome Treatment
    1