BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX

    MDR report key: 3422092 · Received August 19, 2013

    Report

    Report Number
    3422092
    Event Type
    Malfunction
    Date Received
    August 19, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 19, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING PUT ON DIALYSIS. DURING VISUAL INSPECTION OF THE FILTER WITH ONSET A LEAK WAS NOTICED AND PROCEDURE WAS IMMEDIATELY STOPPED. CHARGE NURSE VERIFIED THE LEAK AND THE ARTERIAL SIDE WAS RETURNED BUT THE REST OF THE SYSTEM WAS THROWN OUT. PATIENT DID NOT GET HIS BLOOD RETURNED AND ALREADY HAS A LOW BLOOD COUNT. ADDENDUM: ON VISUAL INSPECTION, THE DIALYZER HAD BLOOD THAT LEAKED OUT INTO THE DIALYSATE COMPARTMENT. LINES WERE IMMEDIATELY CLAMPED AND PATIENT DISCONNECTED FROM MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399355 OPTIFLUX DIALYZER KDI FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC F160 13HU01010
    399356 * * --- FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR