BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREFLOW DIALYSATE CONCENTRATE

    MDR report key: 8902549 · Received August 16, 2019

    Report

    Report Number
    3003464075-2019-00040
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 16, 2019
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    UDI-DI
    M535SAK3040
    PMA / PMN Number
    K140571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED WHICH CONFIRMED THAT THE PRODUCT MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE IS NO INFORMATION TO INDICATE THAT A MALFUNCTION OCCURRED. ADVERSE REACTIONS ARE KNOWN RISKS OF HEMODIALYSIS. INFECTION AND PNEUMONIA ARE KNOWN CONTRIBUTING FACTORS TO ABNORMAL LACTATE LEVELS. BIOCOMPATABILITY HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2019 FROM A NURSE STATING THE (B)(6) FEMALE WITH UNSPECIFIED COMORBIDITIES, EXPERIENCED FATIGUE, SILENT SEIZURES, FELT JITTERY, CLAMMY AND WEAK FOLLOWING HEMODIALYSIS TREATMENTS WITH THE PRODUCT ON MULTIPLE UNSPECIFIED DAYS. NXSTAGE THERAPY WAS DISCONTINUED ON (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED ON 07 AUG 2019 FROM THE NURSE REVEALED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2019 WITH OUT OF RANGE LACTATE LEVELS (NOS), PNEUMONIA AND A CATHETER INFECTION. THE PATIENT RECOVERED WITHOUT SEQUELAE AND REMAINED HOSPITALIZED FOR AN UNRELATED HIP REPLACEMENT, DATE OF DISCHARGE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696006 PUREFLOW DIALYSATE CONCENTRATE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. SAK-304 90479197 M535SAK3040

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization