BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPH170 SYNTHETIC HF DIALYZERHF DIALYZER

    MDR report key: 1822934 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03074
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    June 2, 2010
    Report Date
    August 13, 2010
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    PMA / PMN Number
    K083778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NIPRO BATCH AND RETENTION SAMPLE REVIEW INDICATED: NO ABNORMALITY WAS FOUND IN THE RECORDS OR FINDINGS OF THE BIOLOGICAL TESTS PERFORMED FOR THE LOTS IN THE RELEASE INSPECTION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED; THEREFORE, NO EVALUATION WAS PERFORMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. BAXTER HAS RECEIVED SIMILAR REPORTS OF PATIENT REACTION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A READINGS ISSUE ON THEIR ADC METER WHILE USING AN AFFECTED TEST STRIP LOT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A BAXTER MEDICAL INFORMATION SPECIALIST RECEIVED A CALL FROM A FACILITY DIALYSIS TECHNICIAN REPORTING A PATIENT REACTION USING A XENIUM XPH170 DIALYZER DURING HEMODIALYSIS THERAPY. DURING A FOLLOW UP CALL ON (B)(4) 2010, THE TECHNICIAN INDICATED ONE PATIENT HAD EXPERIENCED REACTIONS ON 5 SEPARATE DATES DURING USE OF A NEW XENIUM DIALYZER ON EACH DATE. ON THE (B)(6) 2010 EVENT DATE, THE PATIENT'S BLOOD PRESSURE DROPPED AT THE END OF THERAPY. THE PATIENT COMPLAINED OF FEELING DIZZY, CONFUSED, LIGHTHEADED, WEAKNESS AND HAD DEVELOPED RESTLESS LEG SYNDROME. COMPONENTS OF THERAPY INCLUDED: TYLENOL, HEPARIN (THE DOSE GIVEN WAS A 3000 UNIT BOLUS AND A 1200 UNITS PER AN HOUR). THE PATIENT'S BLOOD WAS RINSED AND RETURNED TO THE PATIENT WITH EXTRA FLUID (SALINE). THE THERAPY WAS STOPPED. THE PATIENT WAS RELEASED TO HOME. THIS IS THE SECOND EVENT. THE SAMPLES WERE DISCARDED AND THERE ARE NO COMPANION SAMPLES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPH170 SYNTHETIC HF DIALYZERHF DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention TYLENOL, HEPARIN