BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1002520 · Received February 26, 2008

    Report

    Report Number
    3003464075-2008-00083
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYCLER AND CARTRIDGE RETURNED FOR EVALUATION. CYCLER WAS FOUND TO BE WITHIN SPECIFICATION, NO PROBLEMS WERE NOTED. NO DEFECTS OR PROBLEMS WERE NOTED UPON INSPECTION OF THE RETURNED CARTRIDGE. INVESTIGATION IS ONGOING. FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NURSE REPORTS ROUTINE HEMODIALYSIS TREATMENT WAS STOPPED AFTER OBSERVING DARK COLORED EFFLUENT. NURSE REPORTED DIFFICULTY WITH NEEDLE CANNULATION PRIOR TO INITIATING TREATMENT WHICH REQUIRED RECANNULATION OF THE VENOUS NEEDLE. AFTER TREATMENT WAS INITIATED, ARTERIAL PRESSURE ALARMS OCCURRED. NURSE OBSERVED A SMALL CLOT IN THE ARTERIAL LINE, HOWEVER, REPORTED THAT SHE FELT IT WAS SMALL ENOUGH TO BE CAUGHT BY THE FILTER AND CONTINUED WITH THE TREATMENT. THE PT'S ARTERIAL NEEDLE WAS RECANNULATED IN RESPONSE TO THE ARTERIAL PRESSURE ALARMS AND TREATMENT WAS RESTARTED. MULTIPLE FLUID INLET OCCLUSION ALARMS THEN OCCURRED AS A RESULT OF LEAVING A LINE CLAMPED. THE LINE WAS UNCLAMPED AND THE TREATMENT RESUMED. APPROXIMATELY 30 MINUTES LATER, THE PT REPORTED ABDOMINAL GAS AND REQUESTED TO GO TO THE BATHROOM. THE BLOOD WAS RINSEBACKED AND THE EXTRACORPOREAL CIRCUIT PLACED IN RECIRCULATION. PT REPORTED HAVING DIARRHEA AND CHEST PAIN WHICH HE THOUGHT WAS DUE TO ACID REFLUX OR CARDIAC HISTORY WHILE IN THE BATHROOM. PT TOOK TWO NITROGLYCERIN TABLETS WHILE IN THE BATHROOM. TREATMENT WAS RESTARTED AFTER APPROXIMATELY 20 MINUTES WITH PT REPORTING FEELING BETTER. NURSE REPORTS WITHIN A COUPLE OF MINUTES AFTER TREATMENT WAS STARTED, DARK COLORED EFFLUENT WAS OBSERVED AND TREATMENT WAS DISCONTINUED WITHOUT RINSEBACK. PT HAD ANOTHER EPISODE OF DIARRHEA AND COMPLAINED OF CRAMPS IN HIS CALVES, ADD'L ACID REFLUX SYMPTOMS AND CHEST PAIN. O2 WAS GIVEN AT 3I VIA NASAL CANNULA. PT WAS TRANSPORTED TO HOSPITAL FROM DIALYSIS CENTER AND RECEIVED DIALYSIS TREATMENT IN HOSPITAL. PT WAS ADMITTED TO ICU AND DISCHARGED AT LATER UNKNOWN DATE.

    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 7127706

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R