BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE TEXIUM SECONDARY SET

    MDR report key: 20664959 · Received November 12, 2024

    Report

    Report Number
    9616066-2024-01632
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 8, 2024
    Report Date
    March 4, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403198915
    PMA / PMN Number
    K022209
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WAS A LEAK. THREE SAMPLES MODEL 10013364T, LOT 24079174, 24089058, 24059150 WERE RETURNED FOR INVESTIGATION. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SETS WERE PRIMED WITH WATER AND PRESSURIZED AT 30 PSI FOR 10 MINUTES. NO LEAKAGE WAS OBSERVED. THE CUSTOMER COMPLAINT WAS UNABLE TO BE REPLICATED. 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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR FACILITY USES ALARIS PUMPS WHICH ARE CURRENTLY MAINTAINED.

    Description of Event or Problem · 0

    MATERIAL #: 10013364T & BATCH#: 24079174, 24089058, 24059150, 24093001. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OCCURS AT THE CONNECTION SITE BETWEEN THE TEXIUM SECONDARY INFUSION SET AND THE UPPERMOST ALARIS PRIMARY INFUSION SET Y-SITE. THE LEAK CONSISTS OF A SMALL AMOUNT OF DROPLETS FORMING DURING THE INFUSION. IT HAS OCCURRED FROM THE POINT OF 30 MINUTES INTO THE INFUSION TO 45-95 MINUTES OF AN INFUSION. THERE IS NO COMMONALITY OF BASE OR DRUG SOLUTIONS CAUSING THE LEAK. IT HAS OCCURRED A TOTAL OF 5 TIMES IN THE LAST 6 BUSINESS DAYS. OUR FACILITY USES ALARIS PUMPS WHICH ARE CURRENTLY MAINTAINED. VERBATIM: HELLO (B)(6), ONE OF OUR SITES, (B)(6) HAS HAD 5 CASES RECENTLY WHERE CHEMOTHERAPY HAS LEAKED FROM THE TUBING DURING INFUSIONS. MOST RECENT CASE WAS TODAY. DO YOU HAVE A CONTACT YOU CAN PUT US IN TOUCH WITH TO GET ASSISTANCE ON THIS ISSUE? THANKS. ADDITIONAL INFORMATION: INCLUDING CHS SUPPLY CHAIN MANAGER (B)(6). (B)(6), BELOW IS THE COMPLETE LIST OF AFFECTED REFERENCE NUMBERS AND LOTS. THE ITEMS IN RED TEXT WERE INVOLVED IN A SPILL TODAY, (B)(6) 2024. BD SECONDARY INFUSION SET. ITEM NUMBER: 10013364T. SUSPECTED LOTS: (10)24079174, (10)24089058 & (10)24059150. BD ALARIS PUMP INFUSION SET. ITEM NUMBER: 2426-0500. SUSPECTED LOTS 1024083015, 1024083012, 1024073140, 1024073135, 1024063259 & 1024093001. ADDITIONAL INFORMATION: PATIENT 1: 2 OCCURENCES 7 DAYS APART: DATE OF EVENTS: 9/25/2024 & 10/2/2024. PATIENT 2: DATE OF EVENT: 10/8/2024. PATIENT 3: DATE OF EVENT: 10/11/2024. PATIENT 4: DATE OF EVENT: 10/14/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643648 BD ALARIS SMARTSITE TEXIUM SECONDARY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 24059150 10885403198915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown