BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET

    MDR report key: 16865866 · Received May 3, 2023

    Report

    Report Number
    9616066-2023-00817
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 26, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203012430
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THERE WAS OVER-INFUSION COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET INFUSED ZOSYN IN MINUTES DESPITE THE INFUSION BEING SET FOR OVER 3 HOURS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT EVENT REPORTED WITH ZOSYN, WHICH SHOULD HAVE INFUSED OVER 3 HOURS, INFUSED IN MINUTES A. THIS INFUSION WAS DELIVERED AS A SECONDARY INFUSION... D. PRIMARY HAD BEEN INFUSING WITHOUT ANY ISSUES PRIOR TO THE ZOSYN... J. NO PATIENT HARM REPORTED"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET INFUSED ZOSYN IN MINUTES DESPITE THE INFUSION BEING SET FOR OVER 3 HOURS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT EVENT REPORTED WITH ZOSYN, WHICH SHOULD HAVE INFUSED OVER 3 HOURS, INFUSED IN MINUTES THIS INFUSION WAS DELIVERED AS A SECONDARY INFUSION... PRIMARY HAD BEEN INFUSING WITHOUT ANY ISSUES PRIOR TO THE ZOSYN... NO PATIENT HARM REPORTED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432911 BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 07613203012430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED BD¿ SECONDARY IV SET.