BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY)

    MDR report key: 6103296 · Received November 15, 2016

    Report

    Report Number
    2919260-2016-00005
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 18, 2016
    Manufacturer
    MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY)
    Product Code
    FJK
    PMA / PMN Number
    K080807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETAINED FOR INVESTIGATION. THE DESIGN HISTORY FILE FOR THE CARTRIDGE LOT NUMBER WAS REVIEWED AND MET ALL REQUIREMENTS IN THE MANUFACTURING PROCESS PRIOR TO RELEASE WITH NO RELATED DEFECTS. DIALYSIS IS PERFORMED BY TRAINED AND QUALIFIED PERSONNEL WHO PROVIDE CONTINUOUS MONITORING AND CHECK FOR LEAKS DURING TREATMENT IN ORDER TO RESPOND TO ALARMS AND POTENTIALLY HARMFUL CONDITIONS PROMPTLY. THE USER GUIDE WARNS THAT THE USE OF SETS WITH PRIMING VOLUMES THAT EXCEED 10% OF PATIENTS BLOOD VOLUME CAN RESULT IN HYPOVOLEMIC SHOCK OR DEATH.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON OCTOBER 18, 2016 OF AN (B)(6) -OLD PATIENT WHO EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 50ML FROM A LEAK IN THE BLOOD TUBING SET DURING TREATMENT. THE PATIENT RECEIVED 90ML OF ALBUMIN, 60ML OF PACKED RED BLOOD CELLS (PRBC'S) AND PROPHYLACTIC VANCOMYCIN. THE PATIENT CONTINUES TO TREAT AND WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753269 MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) BLOOD TUBING SETS FJK MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) B3-6604M6792 40451001

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Required Intervention