BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLYFLUX REVACLEAR DIALYZER

    MDR report key: 1991178 · Received February 10, 2011

    Report

    Report Number
    3006552611-2011-00002
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    GAMBRO RENAL PRODUCTS
    Product Code
    KDI
    PMA / PMN Number
    K072232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIALYZER INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION AND THE LOT NUMBER COULD NOT BE PROVIDED BY FACILITY.

    Description of Event or Problem · 1

    DURING A HEMODIALYSIS TREATMENT ON A PHOENIX MACHINE, THE PATIENT CODED AND EXPIRED. THE MACHINE WAS INSPECTED BY GAMBRO TECHNICAL SPECIALIST REPRESENTATIVE WHO FOUND IT TO BE FUNCTIONING CORRECTLY AND WITHIN MANUFACTURER'S SPECIFICATIONS. THE DIALYSIS MACHINE WAS RETURNED TO CLINICAL USE. PER DCI CORPORATE POLICY, NO FURTHER PATIENT, TREATMENT, OR DEVICE INFORMATION WILL BE PROVIDED. NEITHER THE PHYSICIAN, NOR THE NURSES CARING FOR THE PATIENT, BELIEVE ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S CARDIAC ARREST. THE CARTRIDGE BLOOD SET, BICART AND REVACLEAR WERE NOT AVAILABLE FOR INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death