BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENIUM XPH

    MDR report key: 3241616 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19070
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    NIPRO CORPORATION USD
    Product Code
    KDI
    PMA / PMN Number
    K083778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE MANUFACTURING RECORDS AND INSPECTION RECORDS REVIEW, NO ISSUES WERE FOUND. DURING RETAINED SAMPLE TESTING, NO ABNORMALITIES WERE FOUND. THERE WAS NO SAMPLE AVAILABLE FOR EVALUATION. AS A RESULT, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT (PT) EXPERIENCED AN ALLERGIC/TOXIC REACTION MANIFESTED BY RESPIRATORY DISTRESS AND NAUSEA COINCIDENT WITH HD THERAPY WITH A XENIUM HEMODIALYZER (FURTHER DETAILS NOT PROVIDED). SUBSEQUENTLY, THE HOSPITAL DISCONTINUED USING THIS KIND OF DIALYZER. AT THE TIME OF THIS REPORT, THE PT WAS IN GOOD CONDITION. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340637 XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION USD 12L10A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other