BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTEZ ELASTOMERIC PUMP

    MDR report key: 16246855 · Received January 25, 2023

    Report

    Report Number
    MW5114504
    Event Type
    Death
    Date Received
    January 25, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 24, 2023
    Manufacturer
    EPIC INTERNATIONAL (THAILAND) CO., LTD.
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT PRESENTED TO CANCER CENTER FOR CONTINUOUS INFUSION OF 5 FU BY ELASTOMERIC PUMP ON (B)(6) 2023. RETURNED FOR DISCONNECT ON (B)(6) 2023 AND REPORTED THAT INFUSION COMPLETED IN 5 HRS. PT PRESENTED TO EMERGENCY DEPT ON (B)(6) 2022 WITH COMPLAINTS OF CHEST ABDOMINAL PAIN STATUS POST SYNCOPAL EPISODE. EXPIRED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485359 SMARTEZ ELASTOMERIC PUMP PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL (THAILAND) CO., LTD. 510K C22E043

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death