BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 14159796 · Received April 20, 2022

    Report

    Report Number
    14159796
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 11, 2022
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN NOTED PATIENT BLOOD PRESSURE HAD DECREASED SIGNIFICANTLY WHILE SHE WAS ASSISTING ANOTHER PATIENT. UPON ARRIVAL TO BEDSIDE, MANIFOLD PIECE HAD DISCONNECTED FROM MANIFOLD, CAUSING VASOPRESSOR TO SUBSEQUENTLY INTO FLOOR INSTEAD OF PATIENT. PATIENT COMPLAINED OF UNWELL FEELING DUE TO SIGNIFICANT DROP IN BLOOD PRESSURE DUE TO UNINTENDED INTERRUPTION OF MEDICATION. MANUFACTURER RESPONSE FOR SET EXT NANOCLAVE MANIFOLD 26" CLEAR MICROCLAVE X2 *CUSTOM*, (BRAND NOT PROVIDED) (PER SITE REPORTER): EMAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648819 ICU MEDICAL STOPCOCK, I.V. SET FMG ICU MEDICAL, INC. AM3014 5162807

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA Female