BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1580445 · Received January 15, 2010

    Report

    Report Number
    3003464075-2010-00006
    Event Type
    Death
    Date Received
    January 15, 2010
    Date of Event
    December 10, 2009
    Report Date
    December 17, 2009
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO CARTRIDGES WERE RETURNED FOR EVALUATION. BOTH CARTRIDGES WERE VISUALLY INSPECTED. NO PROBLEMS OR DEFECTS WERE FOUND. DEVICE HISTORY RECORD REVIEW INDICATES NO QUALITY CONTROL PROBLEMS WERE IDENTIFIED WITH THIS LOT. FIELD SERVICE ENGINEER PERFORMED PRELIMINARY EVALUATION OF THE CYCLER AND FOUND NO PROBLEMS. THE CYCLER IS BEING RETURNED FOR FURTHER EVALUATION AND HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. A FOLLOWUP REPORT WILL BE SUBMITTED IF APPROPRIATE.

    Description of Event or Problem · 1

    PT HAD ABDOMINAL SURGERY AND LEFT NEPHRECTOMY AND WAS RE-ADMITTED WITH SEPSIS AND BILATERAL PNEUMONIA IN 2009 FOLLOWING DISCHARGE THE DAY PRIOR. PT SUBSEQUENTLY HAD MULTIPLE ABDOMINAL SURGERIES INCLUDING A COLON RESECTION, DEBRIDEMENT AND WOUND VAC PLACEMENT. PT EXPERIENCED HYPOTENSION AND ACUTE RENAL FAILURE, CVVHD WAS INITIATED THE FOLLOWING MONTH. NURSE REPORTED EFFLUENT WAS PINK IN COLOR AT 2300 THE FOLLOWING DAY. DIALYSIS THERAPY CONTINUED PER DOCTOR'S INSTRUCTION. AT 1300 THE FOLLOWING DAY, EFFLUENT WAS OBSERVED RED IN COLOR AND TREATMENT DISCONTINUED. TREATMENT WAS RESTARTED WITH A NEW CARTRIDGE. EFFLUENT WAS IMMEDIATELY OBSERVED AS PINK IN COLOR AND TREATMENT STOPPED. ON EVENT DATE, PT TRANSFUSED 2 UNITS OF PRBCS. PT LABS WERE CONSISTENT WITH HEMOLYSIS. TRANSFUSION REACTION WAS RULED OUT. PT CODED AND EXPIRED AT 1953 THE FOLLOWING DAY. CAUSE OF DEATH NOT REPORTED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 9087814

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death