BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1060487 · Received June 13, 2008

    Report

    Report Number
    3003464075-2008-00254
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROBLEM OR DEFECTS WERE FOUND WITH THE RETURNED CARTRIDGE. EXACT CAUSE OF PT SYMPTOMS REMAINS UNK. QC RECORDS INDICATE NO PROBLEMS AND LAL TEST RESULTS FOR THIS LOT OF CARTRIDGES WERE WITHIN SPEC. NO SIMILAR PROBLEMS REPORTED WITH THIS LOT OF CARTRIDGES. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION OCCURRED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    NURSE REPORTED ABOUT 30 MINUTES AFTER START OF A ROUTINE HEMODIALYSIS TREATMENT, THE PT DEVELOPED RIGORS AND TACHYCARDIA. TREATMENT WAS IMMEDIATELY DISCONTINUED, PT WAS TRANSPORTED TO ER AND WAS ADMITTED FOR OBSERVATION. PT WAS AFEBRILE WITH AN ELEVATED WBC OF 35.6. BLOOD, STOOL, AND URINE CULTURES WERE TAKEN. PT WAS GIVEN 1 GRAM VANCOMYCIN IV PROPHYLACTICALLY IN THE ER WITH 125MG VANCOMYCIN TO BE TAKEN ORALLY EVERY 6 HOURS UNTIL CULTURE RESULTS WERE KNOWN. ALL CULTURES WERE NEGATIVE AND VANCOMYCIN DISCONTINUED. PT DISCHARGED 2008. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. PT HAS RETURNED TO DAILY HEMODIALYSIS WITH NXSTAGE SYSTEM ONE WITH NO FURTHER SIMILAR PROBLEMS REPORTED.

    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 8027705

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization