BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX REVACLEAR DIALYZER

    MDR report key: 1636652 · Received March 19, 2010

    Report

    Report Number
    3006552611-2010-00003
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 18, 2010
    Manufacturer
    GAMBRO RENAL PRODUCTS INC.
    Product Code
    KDI
    PMA / PMN Number
    K072232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT USED IN PERFORMING THE PATIENT'S DIALYSIS TREATMENT WAS DISCARDED AND WAS NOT AVAILABLE FOR INSPECTION. HOWEVER, RETAINED SAMPLES FROM THE SAME LOT WERE VISUALLY INSPECTED. THERE WERE NO ANOMALIES FOUND ON SURFACE TESTING AND VISUAL INSPECTION REVEALED, THEY WERE WITHIN MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 1

    A PATIENT COMPLETED A FOUR HOUR UNEVENTFUL DIALYSIS TREATMENT AND DISCHARGED HOME IN STABLE CONDITION. THE FOLLOWING MORNING, THE PATIENT CALLED THE DIALYSIS UNIT AND REPORTED HER SKIN APPEARED TO BE YELLOW/ORANGE IN COLOR. THE PATIENT WAS ADVISED TO REPORT TO EMERGENCY ROOM FOR EVALUATION. THE PATIENT WAS EVALUATED IN THE EMERGENCY ROOM WHERE BLOOD WORK WAS OBTAINED THAT REVEALED AN ELEVATED LDH OF 8,292. THE PATIENT WAS DIAGNOSED WITH HEMOLYSIS AND ADMITTED TO THE HOSPITAL FOR FURTHER OBSERVATION. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION OR OXYGENATION AND WAS DISCHARGED THE FOLLOWING DAY. THE PATIENT HAS SINCE RETURNED TO THE DIALYSIS UNIT FOR HER ROUTINELY SCHEDULED TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX REVACLEAR DIALYZER KDI GAMBRO RENAL PRODUCTS INC. C409111001

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization