BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE CARTRIDGE EXPRESS

    MDR report key: 8037308 · Received November 5, 2018

    Report

    Report Number
    8037308
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 17, 2018
    Report Date
    October 25, 2018
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CVVH MACHINE WITH MULTIPLE ALARM MESSAGE AIR IN FLUID INLET WARMER. THE RN BYPASSED THE WARMER AND MADE DIRECT CONNECTION. OVERNIGHT THE CVVH MACHINE WAS LEAKING. RN ASSESSED TUBING NO APPARENT LEAKS. LOT NUMBER ON CVVH CARTRIDGE WITH AIR ISSUES IS 80878003. MANUFACTURER RESPONSE FOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM, NXSTAGE CARTRIDGE EXPRESS (PER SITE REPORTER): MATERIALS MANAGEMENT SUBMITTED TWO REPORTS AS WE FOUND THIS HAD HAPPENED MULTIPLE TIMES. THE EXACT CVVH TUBING FOR THIS PT. WAS NOT KEPT BUT OTHER CVVH FILTERS WERE RETAINED BY MM TO BE GIVEN TO VENDOR. THE REPORTS WERE SUBMITTED TO THE CRITICAL CARE THERAPY SPECIALIST AT NXSTAGE MEDICAL, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877951 NXSTAGE CARTRIDGE EXPRESS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-505 80878003

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA