BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPH170 SYNTHETIC HF DIALYZERHF DIALYZER

    MDR report key: 1821272 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03022
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    June 4, 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). 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.

    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.

    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. THE REACTIONS WERE WITH XPH170 DIALYZERS, PRODUCT CODE OF H25604A, LOT NUMBER UNKNOWN. THE SAMPLES WERE DISCARDED AND THERE ARE NO COMPANION SAMPLES AVAILABLE. ON THE (B)(6) 2010, 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. THE PATIENT'S BLOOD WAS RINSED AND RETURNED TO THE PATIENT WITH EXTRA FLUID. THE INTERVENTIONS GIVEN WHEN THE REACTION OCCURRED INCLUDED: CHANGED MACHINES, STOPPED HEPARIN, SALINE BOLUSES, INCREASED THE DRY WEIGHT, GAVE TYLENOL, STARTED HIM ON NEURONTIN ON (B)(6) 2010. COMPONENTS OF THERAPY INCLUDED: TYLENOL, HECTOROL, ARANESP. THE PATIENT COMPLETED THE THERAPY WITH THE SAME DIALYZER. THE THERAPY WAS STOPPED. THE FACILITY STAFF CONSIDERED THE USE OF HEPARIN (3000 UNIT BOLUS AND 1200 UNITS PER/HOUR) MAY HAVE CONTRIBUTED TO THE EVENT, THEREFORE, NO HEPARIN WAS GIVEN DURING THIS THERAPY. TWO DAYS AFTER THIS EVENT ((B)(6) 2010) THE PATIENT WENT TO THE HOSPITAL BECAUSE OF A LOW HEMOGLOBIN. THE PATIENT INDICATED HE WAS NOT SURE IF THE LOW HEMOGLOBIN WAS BECAUSE OF THE REACTION ON (B)(6) 2010. INTERVENTION FOR THE LOW HEMOGLOBIN IS UNKNOWN. THE PATIENT WAS ALSO TREATED FOR THE RESTLESS LEG SYNDROME (TREATMENT UNKNOWN). THIS IS THE THIRD EVENT.

    Description of Event or Problem · 1

    CLINIC EMAILED URGENT PRODUCT RECALL OF PRECISION POINT GLUCOSE TEST STRIPS PRODUCED BY (B)(4). (B)(4).

    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, HECTOROL, ARANESP