BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP ADMINISTRATION SET

    MDR report key: 8701210 · Received June 14, 2019

    Report

    Report Number
    9616066-2019-01619
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 23, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203020992
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM CDRH WHICH STATES, ¿RN WENT TO DISCONNECT THE IV TUBING FROM THE PATIENT AS THE FLUIDS WERE DISCONTINUED. WHEN SHE TOOK THE TUBING OUT OF THE PUMP, SHE NOTICED A LARGE BALLOON HAD FORMED AT THE TOP OF THE AIR-SENSING PART OF THE TUBING, NO HARM OBSERVED TO PATIENT". IT WAS LATER REPORTED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT THAT OCCURRED ON THE GENERAL MEDICAL UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493411 ALARIS PUMP ADMINISTRATION SET SET, ADMINISTRATION, INFUSION FPA CAREFUSION 2426-0500 19045907 07613203020992

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR