BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEC 20DP W/SS DC LOW SORB

    MDR report key: 15686261 · Received October 27, 2022

    Report

    Report Number
    9616066-2022-01640
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 28, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403221934
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A PHOTO AS A SAMPLE WAS RECEIVED AND ANALYZED BY OUR QUALITY TEAM. THE SEPARATION IS CLEARLY PRESENTED AND THE COMPLAINT HAS BEEN VERIFIED. WITHOUT FURTHER INFORMATION LIKE A PHYSICAL SAMPLE FOR INVESTIGATION, THE ROOT CAUSE OF THIS SEPARATION REMAINS UNKNOWN. THE MANUFACTURER HAS BEEN MADE AWARE OF THIS ISSUE. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014881 LOT NUMBERS 22039413 (21,603 UNITS PRODUCED 31MAR2022) AND 22029851 (B)(4) UNITS PRODUCED 24FEB2022) WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE BUILD OF THESE SETS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SEC 20DP W/SS DC LOW SORB THE TUBING SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS COMPLAINT WAS STARTED AS WE HAD EXPERIENCE AT LEAST 2 INSTANCES OF THE TUBING COMING DETACHED FROM THE CHAMBER INVOLVING AS MENTIONED BEFORE, THE HOSE ISN¿T BREAKING. THE CONNECTION TO THE CHAMBER JUST ISN¿T SECURE ENOUGH UNDER NORMAL USE AND THEY ARE COMING APART."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SEC 20DP W/SS DC LOW SORB THE TUBING SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS COMPLAINT WAS STARTED AS WE HAD EXPERIENCE AT LEAST 2 INSTANCES OF THE TUBING COMING DETACHED FROM THE CHAMBER INVOLVING. AS MENTIONED BEFORE, THE HOSE ISN¿T BREAKING. THE CONNECTION TO THE CHAMBER JUST ISN¿T SECURE ENOUGH UNDER NORMAL USE AND THEY ARE COMING APART."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796641 BD SEC 20DP W/SS DC LOW SORB INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22039413 10885403221934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown