BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX 210H

    MDR report key: 3882269 · Received June 18, 2014

    Report

    Report Number
    9611369-2014-00012
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 18, 2014
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K043342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIALYZER WAS DISCARDED AND NOT AVAILABLE FOR TECHNICAL INVESTIGATION. GAMBRO PERFORMED A LOT HISTORY RECORD CHECK. THIS LOT WAS PRODUCED AND TESTED WITHOUT ANY NONCONFORMITIES. (B)(4). GAMBRO PERFORMED A COMPLAINT HISTORY FILE CHECK. NO FURTHER COMPLAINT WAS REPORTED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING HOME DIALYSIS THAT INCLUDED A POLYFLUX 210 H DIALYZER. APPROXIMATELY TWO HOURS INTO THE TREATMENT THE PATIENT EXPERIENCED INCREASING ABDOMINAL, HEMATURIA, NAUSEA AND VOMITING. FOLLOWING COMPLETION OF THE DIALYSIS TREATMENT THE PATIENT WENT TO THE HOSPITAL WHERE HE WAS HOSPITALIZED AND DIAGNOSED WITH HEMOLYSIS. UPON ARRIVAL TO THE HOSPITAL THE PATIENT HAD A LOW GRADE FEVER OF 38.2, ICTERIC SCLERA AND THE BLOOD SAMPLES OBTAINED WERE HEMOLYZED. THE PATIENT HAS SINCE BEEN DISCHARGED HOME FROM THE HOSPITAL. THE CAUSE OF THE HEMOLYSIS HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358706 POLYFLUX 210H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 210 H 4-9016-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 41 Hospitalization AK 96, 230V, SELF CARE