BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 21161416 · Received January 15, 2025

    Report

    Report Number
    9616066-2024-02266
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    November 24, 2024
    Report Date
    February 4, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    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

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF FLOW ISSUES BACK FLOW COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET WAS UNDER INFUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTED WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THERE WAS AN UNDER INFUSION OF LIPIDS AND TPN AND THE DEVICE DISPLAYED A BOTTLE-SIDE PRESSURE SENSOR OVER RANGE ERROR (ERROR CODE 240.4150). THE PUMP ALARMED ¿IV INFUSION COMPLETE," HOWEVER THE BAG OF LIPIDS WAS FULL WITH THE TOP 3/4TH OF THE BAG CONTAINING WHITE LIPIDS AND THE BOTTOM 1/4TH CONTAINING YELLOW TPN FROM A DIFFERENT BAG CONNECTED TO THE INFUSION LINE BY Y-SITE CONNECTION. THE CUSTOMER BELIEVED BACKFLOW OF MEDICATION FROM ONE BAG TO THE OTHER OCCURRED. WHEN THE DEVICE WAS EVALUATED BY THE HOSPITAL BIOMED IT DISPLAYED A PRESSURE SENSOR OVER RANGE ERROR (ERROR CODE 240.4150) VERBATIM#:

    Description of Event or Problem · 0

    MATERIAL#: UNKNOWN BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THERE WAS AN UNDER INFUSION OF LIPIDS AND TPN AND THE DEVICE DISPLAYED A BOTTLE-SIDE PRESSURE SENSOR OVER RANGE ERROR (ERROR CODE 240.4150). THE PUMP ALARMED ¿IV INFUSION COMPLETE," HOWEVER THE BAG OF LIPIDS WAS FULL WITH THE TOP 3/4TH OF THE BAG CONTAINING WHITE LIPIDS AND THE BOTTOM 1/4TH CONTAINING YELLOW TPN FROM A DIFFERENT BAG CONNECTED TO THE INFUSION LINE BY Y-SITE CONNECTION. THE CUSTOMER BELIEVED BACKFLOW OF MEDICATION FROM ONE BAG TO THE OTHER OCCURRED. WHEN THE DEVICE WAS EVALUATED BY THE HOSPITAL BIOMED IT DISPLAYED A PRESSURE SENSOR OVER RANGE ERROR (ERROR CODE 240.4150) RCC RECEIVED A COMPLAINT VIA EMAIL. DISPOSABLE COMPLAINT (B)(4) IT WAS REPORTED THAT THERE WAS AN UNDER INFUSION OF LIPIDS AND TPN AND THE DEVICE DISPLAYED A BOTTLE-SIDE PRESSURE SENSOR OVER RANGE ERROR (ERROR CODE 240.4150). THE PUMP ALARMED ¿IV INFUSION COMPLETE," HOWEVER THE BAG OF LIPIDS WAS FULL WITH THE TOP 3/4TH OF THE BAG CONTAINING WHITE LIPIDS AND THE BOTTOM 1/4TH CONTAINING YELLOW TPN FROM A DIFFERENT BAG CONNECTED TO THE INFUSION LINE BY Y-SITE CONNECTION. THE CUSTOMER BELIEVED BACKFLOW OF MEDICATION FROM ONE BAG TO THE OTHER OCCURRED. WHEN THE DEVICE WAS EVALUATED BY THE HOSPITAL BIOMED IT DISPLAYED A PRESSURE SENSOR OVER RANGE ERROR (ERROR CODE 240.4150).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299954 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown