BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIA

    MDR report key: 13544868 · Received February 16, 2022

    Report

    Report Number
    1416980-2022-00576
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    December 1, 2021
    Report Date
    February 16, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED MEDWATCH (B)(4) FOR THIS EVENT. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN UNSPECIFIED ACCESS SET WOULD NOT FLOW. DURING A FENTANYL INFUSION, THE UNSPECIFIED INFUSION PUMPED ALARMED IT WAS COMPLETED; HOWEVER, "THE VIAL WAS STILL COMPLETELY FULL". IV SITE WAS ROTATED AND A BOLUS DOSE WAS ATTEMPTED AND "THERE WAS NO MOVEMENT OF THE INFUSION". THE TUBING AND PUMP WERE EXCHANGED. UPON FURTHER REVIEW BY THE CLINICAL ENGINEER, THE TUBING WAS OBSERVED KINKED JUST BELOW THE DRIP CHAMBER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303010 NIA SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FENTANYL| UNSPECIFIED INFUSION PUMP