BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI FUSER ELASTOMERIC PUMP (250D2 TYPE); PHASEAL CONNECTORS

    MDR report key: 25111982 · Received May 7, 2026

    Report

    Report Number
    MW5187845
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 4, 2026
    Manufacturer
    EPIC INTERNATIONAL (THAILAND) CO., LTD.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT COMING FOR 5-FU DOSI FUSER PUMP DISCONNECT AT THE INFUSION CENTER AND WHITE, POWDERY SUBSTANCE NOTED BETWEEN PHASEAL AND HUBER CLAVE CONNECTION. FLUOROURACIL 100 ML VIAL: LOT #6135297; EXP: 02/2027 FLUOROURACIL 10 ML VIAL: LOT #6134667; EXP: 12/2026 DOSI-FUSER PUMP 250D2. POSSIBLE EXPLANATIONS: -MICROLEAK AT PHASEAL¿CLAVE INTERFACE, EXTERNAL EXPOSURE OF FLUOROURACIL, DRYING, CRYSTALLINE RESIDUE PROBLEM WITH THAT: POSSIBLE HD EXPOSURE; POSSIBLE BREACH IN SYSTEM INTEGRITY; RISK OF CONTAMINATION OR DOSING INCONSISTENCY. DEVICE CODE:1354; 1120. PATIENT CODE: 4582. REFERENCE REPORT# MW5187846.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138569 DOSI FUSER ELASTOMERIC PUMP (250D2 TYPE); PHASEAL CONNECTORS PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL (THAILAND) CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FLUOROURACIL