BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTRIDGE

    MDR report key: 4899559 · Received July 8, 2015

    Report

    Report Number
    8030638-2015-00006
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 8, 2015
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INNOVA CARTRIDGE BLOOD LINE IS SIMILAR TO CARTRIDGE BLOOD LINE WITH 510 (K) APPROVAL - K070414. THE INNOVA CARTRIDGE BLOOD LINE WAS DISCARDED AND NOT AVAILABLE FOR ANALYSIS; 20 RETAINED SAMPLES FROM LOT NUMBER 1000087417 WERE VISUALLY ANALYZED AND THERE WERE NO OBSTRUCTIONS OR KINKS. THE DHR FOR THIS LOT WAS REVIEWED AND THERE WERE NO MANUFACTURING ANOMALIES. IN ADDITION, THE COMPLAINT DATABASE WAS REVIEWED AND THERE WERE NO SIMILAR COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THE ROOT CAUSE OF THE HEMOLYSIS IS NOT KNOWN.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WENT TO THE HOSPITAL WITH ABDOMINAL PAIN THE DAY FOLLOWING A HEMODIALYSIS SESSION THAT INCLUDED AN INNOVA CARTRIDGE BLOOD LINE. THE BLOOD SAMPLE TAKEN FROM THE PATIENT WAS HEMOLYZED AND THE PATIENT¿S HGB WAS DECREASED 2.5 G/DL. ACCORDING TO THE INFORMATION PROVIDED THE PATIENT WAS NOT HOSPITALIZED AND DID NOT RECEIVE A BLOOD TRANSFUSION. THE INNOVA CARTRIDGE BLOOD LINE WAS DISCARDED AND NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441932 CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. 114598 1000087417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other