BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA IV TUBING

    MDR report key: 22896774 · Received August 26, 2025

    Report

    Report Number
    MW5175232
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    August 19, 2025
    Report Date
    August 20, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SETTING UP NEW PATIENT-CONTROLLED ANALGESIA (PCA)- STARTED TO PRIME PCA TUBING AND THEN IT WOULD BEEP OCCLUSION, ATTEMPTED TO HAND PRIME, STILL OCCLUDED. SWITCHED OUT TO NEW TUBING, SAME LOT NUMBER- PRIMED WITHOUT ISSUE. PCA WORKED WITHOUT ISSUE. CLINICAL ENGINEERING AND CENTRAL SUPPLY NOTIFIED. TUBING REFERENCE NUMBER: 10800175 LOT NUMBER: (10)25035517; EXP. (17) 2028-03-23; IDENTIFYING NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379849 PCA IV TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10800175 (10)25035517

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention