BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ DISPOSABLE ELASTOMERIC PUMP

    MDR report key: 9653383 · Received January 30, 2020

    Report

    Report Number
    MW5092645
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 28, 2020
    Manufacturer
    EPIC MEDICAL PTE LTD.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SENT HOME ON (B)(6) 2020 FROM INFUSION CLINIC WITH SMART-EZ ELASTOMERIC PUMP FILLED WITH FLUOROURACIL. PT RETURNED 6 HRS EARLY ON (B)(6) 2020 WHEN HE NOTICED PUMP WAS LEAKING. NURSE NOTED THAT PUMP CONNECTOR WAS BROKEN AND PIECE WAS STUCK TO THE LUER LOCK. MALE CONNECTOR ON PUMP MAY HAVE CRACKED AND CAUSED PUMP TO LEAK. NURSE CLEANED WHITE POWDERY MATERIAL ON SKIN AROUND DRESSING SITE. (B)(4). US. FDA SAEFTY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112127 SMARTEZ DISPOSABLE ELASTOMERIC PUMP PUMP, INFUSION, ELASTOMERIC MEB EPIC MEDICAL PTE LTD. C8M58

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other