BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS F5 HEMOFLOW FILTER

    MDR report key: 975312 · Received January 4, 2008

    Report

    Report Number
    MW5004878
    Event Type
    Injury
    Date Received
    January 4, 2008
    Date of Event
    November 19, 2007
    Report Date
    November 21, 2007
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO PTS HAD SIMILAR EVENTS, ADVERSE REACTIONS USING THE SAME TUBING, DIALYZER AND DIALYSATE. PT 1 STARTED ON DIALYSIS TREATMENT. WITHIN 2 MIN OF BLOOD CIRCULATION PT BEGAN WITH SWELLING OF LIPS, TONGUE, DIFFICULTY BREATHING, VOMITING AND HIVES. BLOOD PUMP IMMEDIATELY STOPPED. BLOOD WAS NOT RETURNED. NS GIVEN FOR VOLUME REPLACEMENT. STAT DOSE OF BENADRYL IV GIVEN. PHYSICIAN NOTIFIED AND AT BEDSIDE. PT GIVEN SOLUMEDROL IV AND ALLOWED TO SIT IN UNIT FOR 3 HRS TILL ABOVE SYMPTOMS DISSIPATED. THE TREATMENT SETUP CONSISTED OF PEDIATRIC MEDISYSTEM TUBING, F5 FRESENIUS DIALYZER, BICART, CENTRISOL ACID BATH, PHOENIX MACHINE 1. PRE TREATMENT PROCESS INCLUDED DIALYZER/SYSTEM PRIME OF 910 ML USING PHOENIX AUTO PRIME W/O UF. RECIRCULATION WAS PERFORMED FOR ABOUT 30 MINS PRE TREATMENT. CHLORINE/CHLORAMINE CHECK NEG, PH, TEMP AND CONDUCTIVITY CHECK IN NORMAL LIMITS. WATER SYSTEM CHECK ALL WITHIN ACCEPTABLE LIMITS. PT 1 HAS BEEN RECEIVING DIALYSIS TREATMENTS USING THE F5 DIALYZER AT 8 MONTHS WITHOUT COMPLICATIONS. PT 1 ATTEMPTED TO DIALYZE AGAIN USING DIFFERENT MACHINE PHOENIX 4 AFTER ALL SYMPTOMS GONE AND PT DETERMINED STABLE PER PHYSICIAN. SAME PROCESS AS ABOVE WAS USED FOR SETUP, SUPPLIES AND PROCEDURES. PT HAD THE SAME RESPONSE ON THE SECOND SET UP AS WELL. PHYSICIAN THOUGHT IT WAS A PT REACTION TO DIALYZER AFTER 2ND ATTEMPT. PT UNABLE TO BE DIALYZED THAT DAY AND WAS ADMITTED TO THE PICU FOR MONITORING DUE TO K+ LEVEL BEING HIGH. PT WAS PLACED ON PERITONEAL DIALYSIS WHICH WAS ALREADY BEING DISCUSSED AS AN OPTION PRIOR TO INCIDENT. PT HAD NO RESIDUAL EFFECT FROM THE EVENT. PT 2 IN 2007, HAD THE SAME SITUATION HAPPEN. PHOENIX 4 MACHINE, F5 DIALYZER, MEDISYSTEM PEDIATRIC TUBING, CENTRISOL ACID BATH AND BICART. ALL PROCEDURES FOLLOWED THE SAME AS LISTED ABOVE. ALL CHECKS ON THE MACHINE AND WATER SYSTEM WERE ACCEPTABLE AND WAS DONE EXACTLY AS ABOVE. THIS PT HAD BEEN ON DIALYSIS WITH THE SAME DIALYZER FOR SEVERAL MONTHS AS WELL. AFTER THIS SECOND EVENT, ALL DIALYSIS TREATMENTS IN THE UNIT WERE DONE PER PORTABLE R/O SYSTEMS. F5 DIALYZERS WERE ELIMINATED FROM THE THERAPIES. NO FURTHER EVENTS HAPPENED. WATER ANALYSIS SAMPLES SENT OFF AND CULTURES DONE TO ELIMINATE ANY PROBLEMS WITH THE R/O SYSTEM. FRESENIUS WAS NOTIFIED OF SITUATION AND F5 DIALYZER BEING THE COMMON ITEM. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: ESRD HEMODIALYSIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS F5 HEMOFLOW FILTER F5 DIALYZER KDI FRESENIUS MEDICAL CARE * 7CU417

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization