BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE

    MDR report key: 17529103 · Received August 12, 2023

    Report

    Report Number
    MW5136032
    Event Type
    Death
    Date Received
    August 12, 2023
    Date of Event
    May 27, 2011
    Report Date
    July 8, 2011
    Manufacturer
    NXSTAGE MEDICAL INC., 43 SOUTH UNION ST., LAWRENCE
    Product Code
    KDI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING FOLLOW UP FROM BAXTER HEALTHCARE TO THE HOME PATIENT'S (HP) CARE GIVER STATED THAT THE HP PASSED AWAY ON (B)(6) 2011, DUE TO A MASSIVE CEREBRAL HEMORRHAGE. (B)(6), DIALYSIS FACILITY WAS CONTACTED. THE DIALYSIS FACILITY INDICATED THE PATIENT WAS NO LONGER ON SERVICE WITH (B)(6). THE PATIENT WAS RECEIVING HOME HEMODIALYSIS UNDER (B)(6) MEDICAL, INC IN (B)(6). (B)(6) MEDICAL. INC WAS CONTACTED AND INDICATED THEY HAD BEEN NOTIFIED OF THE PATIENT DEATH ON (B)(6) 2011. PATIENT INJURY REPORTED: YES. MEDICAL INTERVENTION REQUIRED: YES. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763159 NXSTAGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NXSTAGE MEDICAL INC., 43 SOUTH UNION ST., LAWRENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown