BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1932926 · Received December 14, 2010

    Report

    Report Number
    3003464075-2010-00139
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION IS POSSIBLE WITHOUT THE RETURNED DEVICE. CLINICAL STAFF ATTRIBUTED EVENT TO AN ALLERGIC REACTION. THE USER'S GUIDE INCLUDES ADEQUATE WARNINGS TO MONITOR FOR POTENTIAL ALLERGIC REACTIONS. BIOCOMPATIBILITY OF DEVICE HAS BEEN ESTABLISHED. PT CONTINUES TO DIALYZE WITH SYSTEM ONE AND NO FURTHER SIMILAR PROBLEMS REPORTED DURING USING A DIALYZER FROM A DIFFERENT MFR. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    PT HAD FIRST ROUTINE HEMODIALYSIS TREATMENT ON NXSTAGE SYSTEM ONE AND WAS ASYMPTOMATIC. DURING THE 2ND TREATMENT, APPROX 1 HOUR AFTER INITIATION, PT EXPERIENCED A DECREASE IN BLOOD PRESSURE. ON THE 3RD TREATMENT, PT EXPERIENCED A DECREASE IN BLOOD PRESSURE AT THE START OF THE TREATMENT, A 200CC BOLUS OF SALINE WAS ADMINISTERED AND TREATMENT ENDED WITHOUT RETURNING BLOOD. IT WAS DETERMINED THAT PT WAS HAVING A POSSIBLE DIALYZER REACTION. PT WAS TRANSFUSED WITH 2 UNITS OF PRBCS DUE TO BLOOD LOSS.

    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 9087703

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention