BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ SMARTSITE¿ GRAVITY SET

    MDR report key: 16330784 · Received February 9, 2023

    Report

    Report Number
    9616066-2023-00173
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 18, 2023
    Report Date
    January 23, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CM42500E-07, 510K: THE MODEL # AND CATALOG # IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 42500E-07. THE 510K NUMBER IS FOR THE DOMESTIC SIMILAR PRODUCT: K931173. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED TUBING SEPARATED FROM THE FLUID CHAMBER, AND RETURNED ONE USED SAMPLE. THE SAMPLE INCLUDED ONLY THE DRIP CHAMBER, AND THE SEPARATION WAS CONFIRMED. THE ROOT CAUSE WAS TRACED TO INSUFFICIENT SOLVENT. DEVICE HISTORY RECORD REVIEW FOR MODEL CM42500E-07 AND LOT NUMBER 22109416 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 29OCT2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD ALARIS¿ SMARTSITE¿ GRAVITY SET SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING SEPARATED FROM THE FLUID CHAMBER AT THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606549 BD ALARIS¿ SMARTSITE¿ GRAVITY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22109416

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown