BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE EXTENSION SET

    MDR report key: 18241774 · Received November 30, 2023

    Report

    Report Number
    9616066-2023-02295
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 3, 2023
    Report Date
    January 22, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403235274
    PMA / PMN Number
    K960280
    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

    E1: INITIAL REPORTER FACILITY NAME- (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PR 9211575 - FOLLOW UP MDR FOR ADDITIONAL INFORMATION (SEE B5) AND DEVICE EVALUATION. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKAGE AND BLOOD BACKING UP THE LINE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. DEVICE HISTORY RECORD REVIEW FOR MODEL 37262E LOT NUMBER 23069391 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 05JUL2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET LEAKAGE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: IV TUBING STARTED LEAKING WHILE INFUSING IVF. BLOOD BAKED UP ON THE LINE AND CAUSED A CLOT. IV HAD TO BE REPLACED. DEFECTIVE TUBING REPLACED. SRS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: CUSTOMER RESPONSE: THE LOT NUMBER PROVIDED BY NURSING WAS 1023069391 PERHAPS (10) 23069391. UNFORTUNATELY, THE PACKAGING WAS THROWN AWAY BY NURSING. THEY ALSO DID NOT PROVIDE A DESCRIPTION OF THE DAMAGE/HARM DONE TO PATIENT. ONLY ONE PIECE OF TUBING WAS AFFECTED. JUST LOOKING THROUGH THE BIOHAZARD BAG THAT THE PRODUCT IS IN, I CANNOT SEE ANY DAMAGE. I ALSO DON'T HAVE THAT INFORMATION ON THE PATIENT. SORRY I DON'T HAVE ANY MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539855 BD ALARIS SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 50885403235274

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown