BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 7395295 · Received April 3, 2018

    Report

    Report Number
    MW5076281
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 30, 2018
    Report Date
    March 30, 2018
    Manufacturer
    HALYARD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ECLIPSE HOMEPUMP (MODEL# E252500, LOT# 0202880643) CONTAINING MEROPENEM 1 GRAM IN 0.9% SODIUM CHLORIDE 250 ML TUBING DETACHED FROM DEVICE AND LEAKED OUT CONTENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234352 ECLIPSE HOMEPUMP PUMP, INFUSION FRN HALYARD E252500 0202880643

    Patients

    Seq Age Sex Outcome Treatment
    1