BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 19810658 · Received July 23, 2024

    Report

    Report Number
    9616066-2024-01023
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 25, 2024
    Report Date
    December 23, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF SECONDARY SET WOULD NOT FLOW COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE MATERIAL AND LOT NUMBER ARE UNKNOWN. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNSPECIFIED BD INFUSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED SECONDARY DID NOT INFUSE, 250ML BAG WITH IN LINE VIAL2BAG DEVICE. ALSO PUMP / BAG SET UP WAS NOT CORRECT. AFTER REMOVAL OF THE VIAL2BAG AND CORRECTING THE SET UP, THE SECONDARY INFUSED ON TIME. (250ML/HR)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484223 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown