BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1991183 · Received February 10, 2011

    Report

    Report Number
    8030638-2011-00005
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET 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

    GAMBRO BECAME AWARE OF A PATIENT DEATH DURING A DIALYSIS TREATMENT. THE UNIT DIRECTOR WAS CONTACTED ON (B)(6) 2011. HE STATED, "PER UNIT POLICY, HE COULD NOT PROVIDE ANY INFORMATION REGARDING THE EVENT." THE UNIT DIRECTOR STATED, HE COULD ONLY SAY THAT THERE WAS NO INDICATION THAT THE PHOENIX MACHINE OR ANY OTHER DEVICE/PRODUCT CONTRIBUTED TO THE EVENT. THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION AND THE LOT NUMBER COULD NOT BE PROVIDED BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO CARTRIDGE BLOOD SET BLOOD TUBING SET FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death BAXTER DIALYZER: LOT NUMBER NOT PROVIDED| PHOENIX MACHINE: SN (B)(4)