BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENIUM 190 SYNTH HF DIALYZERSYNTHETIC FOR HEMODIALYSIS

    MDR report key: 985510 · Received January 25, 2008

    Report

    Report Number
    1423500-2008-00033
    Event Type
    Injury
    Date Received
    January 25, 2008
    Date of Event
    December 26, 2007
    Report Date
    December 27, 2007
    Manufacturer
    NIPRO CORPORATION USD
    Product Code
    KDI
    PMA / PMN Number
    K062079
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVAL. HOWEVER, THE MANUFACTURING FACILITY, (NIPRO CORPORATION) HAS BEEN MADE AWARE OF THIS REPORT. A BATCH REVIEW OF THE REPORTED LOT, REVEALED NO ABNORMALITIES. FURTHERMORE, THE MANUFACTURER IS CURRENTLY CONDUCTING BIOLOGICAL TESTS USING A SAMPLE OF THE CONCERNED LOT. THE RESULTS WILL BE PROVIDED TO BAXTER UPON COMPLETION. BAXTER IS MONITORING ISSUES LIKE THIS. AN INVESTIGATION IS STILL PENDING. SHOULD SIGNIFICANT INFO BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER THAT A PT, WHO STARTED DIALYSIS AT THIS FACILITY FEW WEEKS AGO, EXPERIENCED AN UNUSUAL EVENT DURING THE THERAPY. ACCORDING TO THE REPORTER, SHORTLY AFTER THE TREATMENT WAS INITIATED, AN AIR IN LINE ALARM WAS TRIGGERED. THIS ISSUE WAS RESOLVED AS THE CLINICIAN DID FOLLOW THE FACILITY'S PROTOCOL. HOWEVER, LATER INTO THE TREATMENT, DUE TO SEVERE HYPOTENSION, THE PT WAS PLACED IN FLAT TRENDELENBURG POSITION FOR 15 MINS. A 200ML OF NORMAL SALINE SOLUTIONS WAS GIVEN TO THE PT AND THE ULTRAFILTRATION TARGET LOSS REDUCED TO 4L, (STARTED AT 5L). AFTER THE INTERVENTION, THE PT'S STATUS SIGNIFICANTLY IMPROVED. HE WAS ABLE TO COMPLETE THE PRESCRIBED TREATMENT WITHOUT ANY FURTHER MEDICAL CONSEQUENCES. A BLOOD SAMPLE WAS TAKEN FROM THE PT. THE RESULTS WERE REQUESTED, BUT HAVE NOT BEEN RECEIVED YET. A WATER SAMPLE WAS TAKEN FROM THE MACHINE. THE TEST RESULT FROM THE MACHINE CAME BACK AS NEGATIVE. REPORTEDLY, THIS DIALYZER WAS A SINGLE USE (THIS WAS THE ONLY USE OF THIS DIALYZER). THE DIALYZER WAS USED AS DRY PACK (NOT PRE-PROCESSED) AND PRIMED WITH 800ML OF NORMAL SALINE. THE FACILITY HAS A STANDARD RECIRCULATION TIME OF 10 MINS BEFORE PTS ARE CONNECTED TO THE MACHINE. THE PT STARTED USING A XENIUM DIALYZER APPROX FEW WEEKS AGO AND NEVER HAD ANY ISSUE WITH THIS DIALYZER. THE PT WAS DIALYZED VIA LONG-TERM CATHETER. ACCORDING TO THE DIALYSIS FLOW SHEET, THE PT'S TARGET LOSS WAS INITIALLY SET FOR 5.0KG, THE ACTUAL FLUID LOSS WAS 3.2KG. THE PT WAS GIVEN A BOLUS 3000U OF BAXTER HEPARIN AND 2000U HOURLY. IT WAS ALSO REPORTED THAT THIS PT USUALLY TOLERATES THE TREATMENTS WELL. MORE THAN HALF OF THE PTS AT THIS FACILITY USE XENIUM DIALYZERS. THE FACILITY USES GAMBRO PHOENIX HEMODIALYSIS MACHINES. NO OTHER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM 190 SYNTH HF DIALYZERSYNTHETIC FOR HEMODIALYSIS 78KDI KDI NIPRO CORPORATION USD 07G30P07G16P

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention LOT NUMBERS 107066 AND 097081.| GAMBRO PHOENIX HEMODIALYSIS INSTRUMENT| BAXTER HEPARIN SODIUM INJECTION 30ML VIALS