BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1000418 · Received February 20, 2008

    Report

    Report Number
    8030638-2008-00003
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 21, 2008
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K00156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE BLOOD SET FROM THIS INCIDENT WAS NOT RETAINED FOR INSPECTION BUT THE CUSTOMER REPORTED ON STOCK LOT NUMBER 09N157321. RETAIN SAMPLES FROM LOT NUMBER 09N157321 WERE SUBMITTED TO VISUAL INSPECTION, FUNCTIONAL TEST AND PHYSICIAN CHARACTERISTICS AND NO FAILURES WERE FOUND. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO INQUIRE ABOUT HEPARIN PUMP BACKPRESSURE SPECIFICATIONS FOLLOWING A POTENTIAL INCIDENT OF HEMOLYSIS WHERE THE MACHINE GAVE A HEPARIN RATE ERROR ALARM, WHICH IDENTIFIED HIGH BACKPRESSURE ON THE HEPARIN LINE. HOSPITAL TECHNICIAN TESTED THE MACHINE AND OBSERVED AN END-OF-STROKE ALARM AT 700 MMHG. THE CARTRIDGE INVOLVED IS FROM LOT UNK AND THE SAMPLE WAS REPORTED 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. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization