BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE DIALYSATE CONCENTRATE SAK

    MDR report key: 6993547 · Received November 1, 2017

    Report

    Report Number
    MW5073070
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 29, 2017
    Report Date
    October 29, 2017
    Manufacturer
    NXSTAGE
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    NEXSTAGE PURE FLOW DIALYSATE SAK #302, LOT # 70879179, EXP 2019-07-03, LEAKED FROM 0.2 MICRON FILTER IN THE PROCESS OF FILLING THE BAG. NO HEALTH PROBLEM OCCURRED EXCEPT FOR WATER SPILLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774609 NXSTAGE DIALYSATE CONCENTRATE SAK DIALYSATE CONCENTRATE SAK KDI NXSTAGE 70879179

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR