BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3763328 · Received April 17, 2014

    Report

    Report Number
    3003464075-2014-00005
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 18, 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 EVALUATION. 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. THE NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED. THIS REPORT AND THE INFO CONTAINED HEREIN IS SUBMITTED TO THE FOOD & DRUG ADMINISTRATION UNDER 21 CFR PART 803 AND REPRESENTS THE INFO AVAILABLE TO THE COMPANY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    REPORT REC'D FROM A HOME TRAINING NURSE REGARDING A (B)(6) YEAR OLD MALE PATIENT, WHO EXPERIENCED CHEST PAIN AND LOW BLOOD PRESSURE DURING A ROUTINE HEMODIALYSIS TREATMENT. TREATMENT WAS DISCONTINUE, HOWEVER, THE PATIENT BECAME FEBRILE AND COMPLAINED OF NAUSEA. HE WAS SENT TO THE ER WHERE INITIAL LABS (UNSPECIFIED) WERE NORMAL. WITHIN 12 HOURS THE PATIENT EXPERIENCED A DROP IN PLATELETS AND HEMOGLOBIN, AND WBC DROPPED THEN INCREASED (VALUES NOT PROVIDED). THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF NON ST MYOCARDIAL INFARCTION. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234200 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. SAK-302 40179107

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization