BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3775796 · Received April 18, 2014

    Report

    Report Number
    3003464075-2014-00006
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    January 10, 2014
    Report Date
    March 19, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE IDENTIFIED. THE DISPOSABLE CARTRIDGE AND THERAPY FLUID SAK WERE NOT RETURNED FOR EVAL. REVIEW OF THE REPORTED LOT NUMBERS FOUND NO OTHER RELATED COMPLAINTS IN THE COMPLAINT DATABASE. HTN CONFIRMED THE THERAPY FLUID BATCH PASSED REQUIRED TESTING PRIOR TO STARTING TREATMENT. NO FURTHER INVESTIGATION CAN BE PERFORMED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM A HOME TRAINING NURSE REGARDING A (B)(6) FEMALE PT, WHO DURING A ROUTINE HEMODIALYSIS TREATMENT EXPERIENCED HYPOTENSION UNRESPONSIVE TO IV FLUIDS. TREATMENT WAS DISCONTINUED, BP REMAINED LOW WHICH IS NOT UNCOMMON FOR THIS PT. THE PT THEN EXPERIENCED NAUSEA, VOMITING, AND BECOME FEBRILE. SHE WAS MOVED FROM ER TO ICU AND WAS TREATED WITH ONE LITER OF SALINE, AND A PIC LINE INSERTED. INITIAL LABS WERE NORMAL. VASOPRESSORS AND PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. DURING HOSPITALIZATION THE PT EXPERIENCED A DROP IN PLATELETS AND HEMOGLOBIN. WBC INITIALLY DROPPED TO 1.8 AND THEN INCREASED TO 12+. TWO SETS OF BLOOD CULTURES WERE NEGATIVE. PT WAS DISCHARGED AFTER TWO DAYS AND RETURNED HOME WHERE SHE CONTINUED WITH NXSTAGE TREATMENTS WITHOUT FURTHER EVENTS. PT DIAGNOSED WITH VIRAL SEPSIS, CAUSE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238595 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. SAK-302 31179082

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization