BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1970100 · Received January 19, 2011

    Report

    Report Number
    8030638-2011-00003
    Event Type
    Death
    Date Received
    January 19, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    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
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. GAMBRO RECEIVED NO INFO TO SUGGEST THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT AND IT DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL ENGINEER CONTACTED GAMBRO WITH A REQUEST TO INSPECT A PHOENIX MACHINE FOLLOWING A PT DEATH. GAMBRO'S CLINICAL INVESTIGATOR CONTACTED THE CHARGE NURSE, WHO REPORTED THE PT WAS "ACUTELY ILL WITH MANY END-STAGE CO-MORBIDITIES. THE PT WAS UNDERGOING AN UNEVENTFUL DIALYSIS TREATMENT WITH NO PROBLEMS, MACHINE ALARMS, OR OTHER ISSUES, WHEN THE TREATMENT WAS STOPPED SECONDARY TO A CHANGE IN PT STATUS. THE CHARGE NURSE STATED IT WAS AGAINST THE FACILITY'S POLICY TO PROVIDE INFO REGARDING PT EVENTS AND THEREFORE, NO ADD'L INFO WAS PROVIDED. THE CARTRIDGE BLOOD SET HAS BEEN DISCARDED BY THE CLINIC AND WILL NOT BE RETURNED TO GAMBRO. THE PHOENIX MACHINE WAS INSPECTED BY A GAMBRO TECHNICAL SERVICES REP WHO FOUND IT TO BE OPERATING WITHIN MFR'S SPECS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death PHOENIX MACHINE, SN (B)(4)