BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H HEMODIALYZER

    MDR report key: 5543839 · Received April 4, 2016

    Report

    Report Number
    9610987-2016-00001
    Event Type
    Injury
    Date Received
    April 4, 2016
    Date of Event
    January 4, 2016
    Report Date
    April 1, 2016
    Manufacturer
    NIPRO CORPORATION (ODATE)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AFTER 2 HOURS AND 30 MINUTES OF INITIATION OF DIALYSIS TREATMENT, STAFF NOTICED BLOOD WAS LEAKING BETWEEN THE ARTERIAL HEADER AND CASE OF THE DIALYZER. THERE WAS NO LEAKAGE DURING PRIMING. DIALYSIS SESSION WAS STOPPED RIGHT AWAY, AND BLOOD WAS NOT RETURNED. ACCORDING TO THE PHYSICIAN, THE PATIENT LOST ABOUT 400ML OF BLOOD. PATIENT REQUIRED 500ML OF PLASMA RIGHT AWAY. PATIENT'S DIALYSIS ORDER: ON-LIN POST-DILUTION HDF EXPECTED TIME: FOUR (4) HOURS. PARAMETERS 20 MINUTES BEFORE DISCONNECTING PATIENT: BLOOD FLOW RATE: THREE-HUNDRED FIFTY (350) ML/MIN, DIALYSATE FLOWRATE: 600ML/MIN, ARTERIAL PRESSURE: ONE-HUNDRED SEVENTY-ONE (171) MMHG, VENOUS PRESSURE: ONE-HUNDRED THIRTY-NINE (139) MMHG, QFI/QB = 31%(RATIO OF REINFUSION), TOTAL SUBSTITUTION VOLUME: THIRTEEN (13) LITERS, UF/HOURS: 950ML/HOUR, TOTAL UF LOST: TWO-THOUSAND ONE-HUNDRED SEVENTY (2170) ML (PROGRAMMING MADE ON 4 HOURS AND 3.8 LITERS OF WEIGHT LOSS). OTHER MEDICAL EQUIPMENT USED: GAMBRO ARTHIS PHYSIO BLOODLINES, NIPRO AV1525 HTC 15R/AV 1525 TC 15B BLOOD-NEEDLES, ARTHIS PHYSIO DIALYSIS MACHINE PRIMING CONDITIONS FOR DIALYSIS MACHINE: FLOWRATE BETWEEN 100 AND 400 ML/MIN, WITH AN AVERAGE FLOWRATE OF 150ML/MIN (TIME OF PRIMING = 9.3 MINUTES) TOTAL VOLUME: 1400ML AND ANOTHER 300ML BEFORE CONNECTING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201329 NIPRO ELISIO-H HEMODIALYZER DIALYZER KDI NIPRO CORPORATION (ODATE) DD+ELISIO-21H 15J01D

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention