BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE CAR-172 DIALYZER CARTRIDGE

    MDR report key: 17737263 · Received September 12, 2023

    Report

    Report Number
    MW5145577
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    August 29, 2023
    Report Date
    September 8, 2023
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, PATIENT ATTENDED FIRST SCHEDULED HOME HEMODIALYSIS TRAINING USING A NXSTAGE MACHINE. PRE VITAL SIGNS BP-190/103, PULSE-88, TEMP-96.8. AT APPROX. 1340 DIALYSIS TREATMENT WAS INITIATED WITH A USE OF CAR-172 DIALYZER AS PRESCRIBED. WITHIN MINUTES THE PATIENT LOST CONSCIOUSNESS, AND BECAME PULSELESS. NORMAL SALINE ADMINISTERED, CPR INITIATED, 911 ACTIVATED. AT APPROX1347 PATIENT REGAINED CONSCIOUSNESS, EMS(EMERGENCY MEDICAL SERVICES) TRANSPORTED PATIENT TO HOSPITAL AND LATER RELEASED. CAR-172 DIALYZER DISCONTINUED BY PHYSICIAN. CAR-172 DIALYZER ADDED AS AN ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252252 NXSTAGE CAR-172 DIALYZER CARTRIDGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NXSTAGE MEDICAL, INC. 30777107

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Hospitalization HEPARIN| NORMAL SALINE| NXSTAGE WITH PUREFLOW| THERAPY FLUID 1.0 K 40 LACTATE