BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 8945647 · Received August 29, 2019

    Report

    Report Number
    3003464075-2019-00042
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 16, 2019
    Report Date
    August 29, 2019
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    UDI-DI
    M535SAK4030
    PMA / PMN Number
    K140571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE INVOLVED DIALYSATE SACK LOT WAS CONDUCTED WHICH CONFIRMED THE PRODUCT MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE IS NO EVIDENCE TO SUGGEST THAT A PRODUCT MALFUNCTION OCCURRED. THE USER GUIDE PROVIDES INSTRUCTION TO MAINTAIN ASEPTIC TECHNIQUE AND WARNINGS TO FOLLOW INSTRUCTIONS PROVIDED TO PREVENT THE RISK OF EXPOSURE TO INFECTIOUS DISEASES. BIOCOMPATIBILITY OF THE DEVICE HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE CAREGIVER OF A (B)(6) YEAR OLD MALE WITH END STAGE RENAL DISEASE, ANEMIA, AND DIABETES WHO EXPERIENCED NUMBNESS IN HIS ARM, A BURNING SENSATION, AND SHIVERS 40 MINUTES INTO STANDARD HOME HEMODIALYSIS TREATMENT ON (B)(6) 2019. THE PATIENT WAS TAKEN TO HOSPITAL WHERE BLOOD CULTURES SHOWED NO GROWTH. PROPHYLACTIC ANTIBIOTICS (NOS) WERE ADMINISTERED, SYMPTOMS RESOLVED, AND THE PATIENT WAS DISCHARGED (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738590 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. SAK-403 81079205 M535SAK4030

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R