BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 15454362 · Received September 20, 2022

    Report

    Report Number
    3003464075-2022-00053
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 20, 2022
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K111174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION AND DISPLAYED SIGNS OF A HIGH ENERGY EVENT. EXTERNAL INSPECTION OF THE POWER ENTRY MODULE AND POWER CORD FOUND EVIDENCE OF DAMAGE CONSISTENT WITH FLUID INGRESS TO THE POWER CONNECTION. INTERNAL INSPECTION OF THE CONTROL UNIT SHOWED NO DAMAGE DUE TO HIGH HEAT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED WHICH CONFIRMED THAT THE DEVICE MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE MEETS REQUIREMENTS FOR ELECTRICAL AND SAFETY STANDARDS AS OUTLINED IN THE USER GUIDE. THE USER GUIDE CONTAINS A PRECAUTION TO VERIFY THE CONTROL UNIT AND POWER CORD SHOW NO SIGN OF EXTERNAL DAMAGE PRIOR TO USE. IF THE UNIT IS DAMAGED, FOLLOW THE PRODUCT RETURN PROCEDURE DESCRIBED IN THIS MANUAL. IT WARNS TO PLUG THE UNIT INTO A PROPERLY GROUNDED OUTLET AND DESCRIBES CONNECTION FOR THE POWER CORD FROM A GROUNDED POWER OUTLET TO THE BACK OF THE UNIT. PER THE USER GUIDE PROPER ELECTRICAL HOOKUP IN FULL COMPLIANCE WITH ALL APPLICABLE CODES AND DEVICE SPECIFICATIONS MUST BE MAINTAINED. DETAILS OF THE ELECTRICAL CONNECTIONS MADE DURING USE ARE UNKNOWN. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON (B)(6) 2022 FROM A 51 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED THEIR PUREFLOW SL CONTROL UNIT CAUGHT FIRE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON 29 AUG 2022 FROM THE HOME THERAPY NURSE (HTN) WHO CONFIRMED THERE WAS NO ADVERSE IMPACT TO THE USER OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646464 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. NX2000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other