BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET

    MDR report key: 23466889 · Received November 4, 2025

    Report

    Report Number
    9616066-2025-03357
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 10, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403240959
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. ALTHOUGH WE COULD NOT CONFIRM THE REPORTED FAILURE, A TREND HAS BEEN IDENTIFIED AND ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THE ISSUE. CORRECTIVE ACTIONS TAKEN DURING THIS INVESTIGATION WILL BE IMPLEMENTED IN OUR PRODUCTION PROCESS TO FURTHER INCREASE THE ROBUSTNESS AND RELIABILITY OF THE DEVICE AND PREVENT FUTURE OCCURRENCES OF THIS TYPE. BD MANUFACTURING HAS BEEN INFORMED OF THIS ISSUE. A FAILURE INVESTIGATION MEMO AND CORRECTIVE ACTION (TRACKWISE CAPA PR 11421784) HAVE BEEN INITIATED. THIS SET WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION DATE FOR THIS CAPA. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL# 24601-B007T AND LOT# 25025433 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 21FEB2025 .THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    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

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ETOPOSIDE LEAKED ONTO PATIENT- ROUGHLY 12 IN X 12 IN WET SPOT-ON PATIENT'S SHIRT. NO SKIN IRRITATION AT THIS TIME. PATIENT CLEANED UP AND CHANGED OUT OF SOILED CLOTHING. INSTRUCTED TO WASH SOILED CLOTHING SEPARATELY. PROVIDER NOTIFIED. PRIMARY TEXIUM TUBING REF 24601-B007T LOT 25025433 EXP 2/21/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777166 BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 25025433 10885403240959

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown