BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 7320524 · Received March 6, 2018

    Report

    Report Number
    MW5075723
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 28, 2018
    Report Date
    March 5, 2018
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TWO ECLIPSE HOMEPUMPS (MODEL# E252500, LOT# 0202849857) CONTAINING ZITHROMAX 500MG IN 0.9% SODIUM CHLORIDE 250 ML HAVE DEFECTIVE INNER (ONE CONTAINING NS ONLY). NOTICED BY TECH DURING COMPOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162559 ECLIPSE HOMEPUMP PUMP, INFUSION, ELASTOMERIC MEB E252500 0202849857
    162570 ECLIPSE HOMEPUMP PUMP, INFUSION, ELASTOMERIC MEB HALYARD E252500 0202849857

    Patients

    Seq Age Sex Outcome Treatment
    1