BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENIUM 150 SYNTH HF DIALYZERSYNTHETIC FOR HEMODIALYSIS

    MDR report key: 985511 · Received January 25, 2008

    Report

    Report Number
    1423500-2008-00032
    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 SAMPLES 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 EXPERIENCED AN ADVERSE REACTION DURING A HEMODIALYSIS TREATMENT. REPORTEDLY, 5 MINS WITHIN THE TREATMENT, THE PT BECAME HYPOTENSIVE, STARTED COMPLAINING OF FEELING OF WARMTH AND HAD NAUSEA, HEART PALPITATIONS AND EYES WATERING. PER THE FACILITY'S PROTOCOL THE TREATMENT WAS TEMPORARILY DISCONTINUED, 200ML NORMAL SALINE SOLUTION WAS GIVEN TO THE PT, AND THE ULTRAFILTRATION TARGET LOSS REDUCED TO 4.0L, (STARTED AT 5.0L). AFTER THE INTERVENTION, THE PT WAS ABLE TO COMPLETE THE TREATMENT WITHOUT ANY FURTHER MEDICAL CONSEQUENCES. AT THE END OF THE TREATMENT THE STAFF AT THE CLINIC REVIEWED WITH THE PT DIRECTIONS FOR TAKING HER BLOOD PRESSURE MEDICATION. 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 PT STARTED USING THE XENIUM DIALYZER APPROX ONE YR AGO AND NEVER HAD ANY ISSUE WITH IT. MORE THAN HALF OF THE PTS AT THIS FACILITY USE XENIUM DIALYZERS. THE FACILITY USES GAMBRO PHOENIX HEMODIALYSIS MACHINES. THE FACILITY HAS A STANDARD RECIRCULATION TIME OF 10 MINS BEFORE PTS ARE CONNECTED TO THE INSTRUMENT. THE PT WAS DIALYZED VIA LONG-TERM CATHETER. THE PT PRE-WEIGHT WAS 64.2KG AND THE TARGET LOSS WAS INITIALLY SET FOR 5.0KG, (IDEAL WEIGHT, 59KG), BUT THE ACTUAL FLUID LOSS THIS DAY, WAS 2.5KG. THE PT WAS GIVEN A BOLUS 1500U OF BAXTER HEPARIN AND 1000U UNITS HOURLY. ULTIMATELY IT WAS REPORTED THAT THIS PT USUALLY TOLERATES THE TREATMENTS WELL AND DID NOT HAVE SIMILAR REACTIONS BEFORE. NO OTHER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM 150 SYNTH HF DIALYZERSYNTHETIC FOR HEMODIALYSIS 78KDI KDI NIPRO CORPORATION USD 07E10P07D16P

    Patients

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