BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE MEDICAL PEDIATRIC MEDICAL, INC.

    MDR report key: 8735048 · Received June 25, 2019

    Report

    Report Number
    MW5087603
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 14, 2019
    Report Date
    June 21, 2019
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PEDIATRIC NXSTAGE MACHINE HAD TWO CRITICAL ALARMS ON TWO DIFFERENT PUMPS WHILE PRIMING. THE FIRST WAS A BLOOD LEAK ALARM AND THE SECOND ON THE OTHER PEDIATRIC MACHINE WAS A THERAPY FLUID BALANCE CARTRIDGE LEAK (RED ALARM 90). BOTH TIMES THE DISPOSABLE EQUIPMENT WAS THROWN OUT AND HE SET UP PROCESS STARTED WITH A NEW MACHINE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526687 NXSTAGE MEDICAL PEDIATRIC MEDICAL, INC. DIALYSIS, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NXSTAGE MEDICAL, INC. 81077018

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO