BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1972278 · Received January 21, 2011

    Report

    Report Number
    3003464075-2011-00009
    Event Type
    Death
    Date Received
    January 21, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FUNCTIONAL PROBLEMS WERE FOUND WITH THE RETURNED CYCLER. ANALYSIS OF THE TREATMENT DATA LOG FILE INDICATES THAT THE CYCLER WAS PERFORMING AS INTENDED AND BOTH OF THE VENOUS AIR SENSORS INDICATED THAT THERE WAS NO AIR PRESENT IN THE VENOUS BLOOD LINE DURING THE TREATMENT. EVAL OF THE RETURNED CAR IDENTIFIED A FLUID LEAK IN THE FLUID MANAGEMENT PATHWAY OF THE CARTRIDGE AT A WELD SEAM. THERE HAVE BEEN NO OTHER SIMILAR DEFECTS NOTED ON ANY OTHER RETURNED CARTRIDGES. THIS APPEARS TO BE A RANDOM AND ISOLATED MFG ERROR THAT IS UNRELATED TO THE ADVERSE EVENT. FACILITY NURSE REPORTS THAT PT HAD A FRAGILE CARDIAC STATUS AND DOES NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PT DEATH. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    ABOUT 1.5 HRS INTO A ROUTINE HEMODIALYSIS TREATMENT, THE PT ALERTED OPERATOR TO ALARMS. OPERATOR NOTED CLEAR FLUID ON TABLE TOP SURFACE AND THAT THERE WAS NO POWER TO CYCLER AND INITIATED A MANUAL RINSEBACK OF THE PT'S BLOOD. NEAR THE END OF THE MANUAL RINSEBACK PROCEDURE, THE OPERATOR OBSERVED CLEAR FLUID LEAKING FROM CARTRIDGE AND AIR IN THE PT VENOUS LINE AND DISCONTINUED THE MANUAL RINSEBACK. THE PT HAD BEEN CONVERSING WITH THE OPERATOR DURING THE RINSEBACK BUT THEN BECAME UNRESPONSIVE. CPR WAS INITIATED AND 911 CALLED; PT WAS TRANSPORTED TO HOSPITAL AND EXPIRED. PT WAS DNR. PT HAD A HISTORY OF CARDIAC PROBLEMS AND HAD RECENTLY BEEN HOSPITALIZED WITH A POOR PROGNOSIS. PT WAS RECEIVING 3-5L OF OXYGEN VIA NASAL CANNULA. NO AUTOPSY WAS PERFORMED. PRIMARY CAUSE OF DEATH REPORTED AS CARDIAC ARREST CAUSE UNK; SECONDARY CAUSE OF DEATH REPORTED AS CONGESTIVE HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170-B 0077713

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death