BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 8579662 · Received May 3, 2019

    Report

    Report Number
    3003464075-2019-00014
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 3, 2019
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    UDI-DI
    M535SAK4030
    PMA / PMN Number
    K140571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE HOME THERAPY NURSE (HTN) OF A (B)(6) MALE WITH MULTIPLE COMORBIDITIES INCLUDING END-STAGE RENAL DISEASE (ESRD) AND ELEVATED LIVER FUNCTION TESTS (LFT), WHO EXPERIENCED HEADACHE, FEVER (104.5 F), TACHYCARDIA (117 BPM), NUMBNESS/TINGLING IN HIS FINGERS, LOWER BACK PAIN, CHILLS, HYPOTENSION (98/58), AND INCREASED LETHARGY APPROXIMATELY 50 MINUTES AFTER INITIATING HIS FIRST IN-CENTER HEMODIALYSIS TREATMENT WITH THE DIALYSATE SACK ON (B)(6) 2019. THERAPY WAS TERMINATED, INTRAVENOUS (IV) VANCOMYCIN (1.5G) & CEFTAZIDIME (1.5G) WERE ADMINISTERED, AND THE PATIENT BECOME UNRESPONSIVE. NASAL OXYGEN (O2) WAS APPLIED, AND THE PATIENT WAS TRANSPORTED VIA AMBULANCE AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 FROM THE HTN REVEALED THAT EVALUATION IN HOSPITAL INCLUDED BLOOD AND STOOL CULTURES WITH NO ORGANISM IDENTIFIED. VIRAL SYNDROME WAS SUSPECTED, AND THE IV ANTIBIOTICS WERE CEASED. FURTHER BLOOD TESTS, ELECTROCARDIOGRAM (EKG) AND CHEST X-RAY (CXR) REVEALED NO CAUSATIVE FACTORS. THE PATIENT RECEIVED A DIAGNOSIS OF SEPSIS WITH ACUTE ORGAN DYSFUNCTION AND WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372883 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. SAK-403 90179285 M535SAK4030

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization