BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 20290411 · Received September 24, 2024

    Report

    Report Number
    20290411
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 30, 2024
    Report Date
    August 30, 2024
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WAS PRIMING IVIG (INTRAVENOUS IMMUNOGLOBULIN) ON LONG PRIMARY TUBING. DRUG PRIMES SLOW D/T (DUE TO) THICKNESS, WRITER UNCURLED THE LINE TO ALLOW DRUG TO PRIME & LINE BROKE IN HALF AT THE SITE JUST BELOW THE SAFETY CLAMP BELOW WHERE THE LINE PLUGS INTO THE PUMP. LINE DISCARDED & NEW LINE USED FOR PRIMING. PATIENT UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878857 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SARL 2426-0007 24069148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown