BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE BLOOD INFUSION SET

    MDR report key: 21970326 · Received May 6, 2025

    Report

    Report Number
    9616066-2025-01135
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    March 30, 2025
    Report Date
    May 20, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203019668
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    ONE SAMPLE WAS RECEIVED FOR QUALITY EVALUATION. VISUAL EXAMINATION WAS CONDUCTED AND NO DAMAGES OR ABNORMALITIES WERE IDENTIFIED. THE SET WAS THEN PRIMED WITH WATER. A BAG OF WATER AND BLUE DYE WAS CONNECTED TO ONE SPIKE AND A BAG OF CLEAR WATER WAS CONNECT TO THE OTHER SPIKE. A SIMULATED INFUSION, AT A RATE OF 125 ML/HR WAS THEN CONDUCTED WITH EACH OF THE INFUSION INLET LINES CLAMPED IN ORDER TO KEEP THE TWO LIQUIDS FROM BACK FLOWING INTO THE OTHER BAG. THERE WERE NO SIGNS OF LEAKAGE, AIR-IN-LINE, OCCLUSION OR BACKFLOW. THE CUSTOMER COMPLAINT OF BACKFLOW COULD NOT BE VERIFIED. A ROOT CAUSE FOR THE FAILURE COULD NOT BE DETERMINED BECAUSE THE FAILURE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10062818 LOT NUMBER 23125284 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 THE BD ALARIS PUMP MODULE BLOOD INFUSION SET HAD A DEFECTIVE CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NOTICED THAT MY BLOOD IN THE TUBING LOOKED SUPER DILUTED. I TRACED IT UP TO THE BAG AND THE BAG LOOKED OVERFILLED AND DILUTED BUT IF YOU TRACE THE TUBING CLOSER TO THE PATIENT IT DIDN'T LOOK DILUTED. I MADE SURE TO CHECK MY CLAMP ON MY NS SIDE AND THE CLAMP WAS IN PLACE AND DIDN'T APPEAR TO HAVE ANY ISSUES. I FINISHED WHAT WAS LEFT OF THE BLOOD AND PUT ON MY FLUSH AND A COUPLE MINS LATER I GO BACK IN BECAUSE IT IS BEEPING AIR IN LINE. SOMEHOW MY NS BAG RAN COMPLETELY DRY. SO, WHILE THE BLOOD WAS INFUSING, DESPITE BEING CLAMPED MY NS WAS BACK PRIMING INTO MY BLOOD BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67688 BD ALARIS PUMP MODULE BLOOD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23125284 07613203019668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown