BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENIUM XPH

    MDR report key: 2213892 · Received August 17, 2011

    Report

    Report Number
    1423500-2011-10785
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 1, 2011
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    PMA / PMN Number
    K083778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLARIFICATION OF INFORMATION: THE PATIENT REACTION WAS NOTED 30 MINUTES INTO THERAPY DEVICE ALARMED AIR IN BLOOD ALARM, THEN THE PATIENT EXPERIENCED SYMPTOMS FEELING "QUEASY" AND WAS HYPOTENSIVE (BLOOD PRESSURE 73/36). A SALINE BOLUS WAS ADMINISTERED. THE PATIENT COMPLETED THERAPY WITH THE SAME DIALYZER WITHOUT DIFFICULTY. THIS IS A SINGLE USE DIALYZER. SAGENT HEPARIN 3000 U BOLUS WITH 1500U HOURLY WAS ADMINISTERED. THE PATIENT HAS USED THIS DIALYZER SINCE (B)(6) 2011. PREVIOUSLY THE PATIENT USED A CT190 DIALYZER.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO SAMPLE FOR EVALUATION. THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURER, NIPRO, PERFORMED A BATCH REVIEW AND RETENTION SAMPLE REVIEW. RESULTS INDICATE: THE MANUFACTURING RECORDS, PROCESS INSPECTION RECORDS AND RELEASE INSPECTION RECORDS OF THE LOTS CONCERNED WERE REVIEWED AND NO ABNORMALITY WAS FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION OR BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED. THIS REPORT IS THE THIRD OF SEVEN.

    Description of Event or Problem · 1

    THE FACILITY CLINICAL COORDINATOR CONTACTED BAXTER PRODUCT SURVEILLANCE TO REPORT THE PATIENT HAVING MULTIPLE INCIDENCES OF PATIENT REACTIONS WITH BAXTER DIALYZERS OVER THE PAST FEW MONTHS. SHE STATED THAT THE PATIENT SYMPTOMS INCLUDED: LIGHT HEADEDNESS, NAUSEA, SHORTNESS OF BREATH (SOB) AND COUGHING UP FROTHY EMESIS. THIS OCCURRED 7 TIMES WITH THE SAME PATIENT: IN (B)(6) 2011. SHE STATED THAT THERE WAS AN AIR IN BLOOD ALARM ON THE GAMBRO MACHINE TODAY AND THAT SHE HAS ALREADY TALKED WITH GAMBRO TODAY ABOUT THE ALARM ON THE MACHINE. SHE STATED THAT THE PATIENT HAD THE SYMPTOMS IN (B)(6) RIGHT AFTER THE AIR IN BLOOD ALARM ON THE MACHINE AND THEY WERE NOT SURE IF THE SYMPTOMS WERE RELATED TO THE DIALYZER AT THE TIME. SHE STATED THAT IN (B)(6), TWO OF THEIR GAMBRO MACHINES HAD AIR ALARM PROBLEMS, BUT SHE WAS NOT SURE IF THE PATIENT HAD BEEN ON EITHER OF THESE 2 MACHINES BACK IN (B)(6). SHE STATED THAT THE PATIENT HAD 3 INCIDENCES IN THE MONTH OF MAY AFTER THE MACHINES WERE FIXED. THEN THE PATIENT HAD THE SYMPTOMS ON (B)(6) 2011. THE BLOODLINES USED WERE FROM GAMBRO, THE MACHINE WAS GAMBRO, AND THE FISTULA NEEDLE IS FROM (B)(4). THE SYMPTOMS OCCURRED AT THE ONSET OF TREATMENT. THERE WAS NO HOSPITALIZATION WAS REQUIRED. THE PATIENT WAS GIVEN OXYGEN, ULTRAFILTRATION WAS DECREASED, BLOOD FLOW RATE WAS DECREASED AND THE PATIENT RECOVERED WITHIN 10 MINUTES. ON (B)(6) 2011, THE PATIENT WAS DIALYZED ON A CT 190 WITHOUT EXPERIENCING ANY SIGNS OR SYMPTOMS OF REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 11A01A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention