BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE LOW SORBING EXTENSION SET

    MDR report key: 17907602 · Received October 10, 2023

    Report

    Report Number
    9616066-2023-02026
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 16, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203012264
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9001933 FOLLOW UP FOR MDR SUBMISSION FOR DEVICE EVALUATION. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF SEPARATION OTHER COMPONENT - LEAK COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL# 20350E AND LOT# 23059076 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 04MAY2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E4. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 14 SEPT , 2023 . MEDWATCH REPORT # MW MW5145817. H3. 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

    NO ADDITIONAL INFORMATION: MATERIAL#: 20350E, BATCH NUMBER#: 23059076. IT WAS REPORTED BY CUSTOMER THAT FILTER SNAPPED IN TWO WHILE PRIMING FLUIDS. BD SMARTSITE LOW SORBING EXTENSION SET 0.2 MICRON LOW PROTEIN BINDING FILTER. (B)(4). VERBATIM#: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. "FILTER SNAPPED IN TWO WHILE PRIMING FLUIDS. BD SMARTSITE LOW SORBING EXTENSION SET 0.2 MICRON LOW PROTEIN BINDING FILTER. (B)(4)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE LOW SORBING EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: "FILTER SNAPPED IN TWO WHILE PRIMING FLUIDS. BD SMARTSITE LOW SORBING EXTENSION SET 0.2 MICRON LOW PROTEIN BINDING FILTER. (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282645 BD ALARIS SMARTSITE LOW SORBING EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23059076 37613203012264

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown