BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 2253524 · Received September 15, 2011

    Report

    Report Number
    8030638-2011-00019
    Event Type
    Death
    Date Received
    September 15, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 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 DISCARDED AND, THEREFORE, WAS NOT AVAILABLE FOR INVESTIGATION. GAMBRO IDENTIFIED THE LOT NUMBERS OF THE LAST 3 SHIPMENTS OF BLOOD TUBING SETS SENT TO THIS CUSTOMER (1000010502, 1000012148 AND 1000012907). FUNCTIONAL, DIMENSIONAL AND LEAK TESTS AND VISUAL INSPECTION WERE PERFORMED ON 45 SAMPLES FROM THOSE LOTS. THERE WERE NO FAILURES OR DEFECTS FOUND IN ANY OF THE SAMPLES TESTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GAMBRO TO HAVE THE PHOENIX MACHINE INSPECTED FOLLOWING A PATIENT DEATH. ACCORDING TO THE UNIT DIRECTOR, IT IS THEIR POLICY TO HAVE THE MACHINE INSPECTED FOLLOWING A DEATH. THE UNIT DIRECTOR STATED THAT THERE WERE NO ALARMS OR ANY PROBLEMS WITH THE PHOENIX MACHINE PRIOR TO THE EVENT. THE CAUSE OF THE EVENT WAS REPORTED TO BE "HEART TROUBLES"; NO ADDITIONAL INFORMATION WAS PROVIDED. THE PHOENIX MACHINE WAS INSPECTED BY A GAMBRO TECHNICAL SERVICES REPRESENTATIVE AND IT WAS FOUND TO BE OPERATING WITHIN MANUFACTURER SPECIFICATIONS. THE CARTRIDGE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS DISCARDED, THEREFORE, WAS NOT AVAILABLE FOR INVESTIGATION.

    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. NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PHOENIX MACHINE: SN (B)(4), SWV 3.36| BICART: LOT # UNKNOWN