BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX F250NRE DIALYZER

    MDR report key: 4091629 · Received August 22, 2014

    Report

    Report Number
    1713747-2014-00405
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K082414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING PT MEDICAL RECORDS AND TREATMENT DATA INFO REGARDING THE REPORTED HOSPITALIZATION AND DIAGNOSIS OF HEMOLYSIS. ACCORDING TO THE BMT, EXCEPT FOR THE 250 DIALYZER, THERE WERE NO OTHER FRESENIUS PRODUCTS IN USE DURING THE TREATMENT. A SEARCH OF THE DELIVERY HISTORY CONFIRMS THIS. HE REPORTS ALL TESTS FOR CHEMICAL RESIDUAL IN THE LOOP AND DIALYSIS MACHINE WERE NEGATIVE. THERE WERE NO REPORTS OF MACHINE CONDUCTIVITY OR TEMPERATURE PROBLEMS PRIOR TO OR DURING TREATMENT AND THE MACHINE'S PERIODIC MAINTENANCE IS BEING DONE EVERY 6 MONTHS. HE DENIES ANY ELEVATED WATER/DIALYSIS CULTURES. ACCORDING TO THE NURSE MANAGER, THE PT WAS THE ONLY PT IN THE UNIT HOOKED INTO THE CENTRAL DIALYSATE DELIVERY SYSTEM. ALL OTHER PTS WERE RUNNING ON JUG DIALYSATE REPORTEDLY, BECAUSE THE BICARB TO THE CENTRAL SYSTEM WAS "LOW". HE STATES NO CONCLUSIONS HAVE BEEN REACHED RE: THE CAUSE OF THE EVENT. ADDITIONALLY, HE CANNOT RULE OUT "A PRIMING ISSUE OR OTHER ERROR". THE PLANT INVESTIGATION IS ON-GOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A BIOMEDICAL TECH (BMT) REPORTED TO TECHNICAL SUPPORT THAT A HEMODIALYSIS PT "EXPERIENCED" HEMOLYSIS DURING A HEMODIALYSIS TREATMENT. ACCORDING TO THE BMT UPON F/U OF THE EVENT, HE WAS INQUIRING TO TECHNICAL SUPPORT ABOUT THE STATUS OF ANY RECALLS OF THE DIALYZER IN AN EFFORT OF DUE DILIGENCE IN THE CLINIC INVESTIGATION INTO THE POSSIBLE CAUSE OF THE EVENT OF HEMOLYSIS. ADD'L F/U WAS DONE WITH THE NURSE MANAGER WHO REPORTED THE PT PRESENTED TO TREATMENT IN HIS USUAL STATE OF HEALTH. HIS ARTERIOVENOUS FISTULA WAS ACCESSED WITHOUT ISSUE AND NO INDICATION OF ANY PROBLEM WAS NOTED WITH THE TREATMENT. APPROX 40 MINUTES INTO THE TREATMENT, THE PT BECAME DIAPHORETIC, COMPLAINED OF A HEADACHE, AND WAS "UNCOMFORTABLE". THE STAFF PERSON RINSED BACK THE PT'S BLOOD AND THE NURSE MANAGER NOTED IT HAD A "BROWN COLOR". HE DENIED BLOOD LOSS. THE PT WAS STILL DIAPHORETIC AND UNCOMFORTABLE AND WAS SENT TO THE EMERGENCY ROOM VIA AMBULANCE. HE WAS ADMITTED TO THE HOSPITAL AND WAS DISCHARGED HOME ONE WEEK LATER. THE NURSE MANAGER DENIES ANY KNOWLEDGE OF TREATMENT RECEIVED WHILE ADMITTED. PT HAS RESUMED HIS THRICE WEEKLY HEMODIALYSIS TREATMENTS WITHOUT FURTHER ISSUE. THE DIALYZER WAS DISCARDED AND IS THEREFORE, NO AVAILABLE FOR MFR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508083 OPTIFLUX F250NRE DIALYZER KDI FRESENIUS MEDICAL CARE NORTH AMERICA 13SUO2016

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R 2008K HEMODIALYSIS MACHINE