BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE

    MDR report key: 3848529 · Received June 4, 2014

    Report

    Report Number
    8030638-2014-00008
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 4, 2014
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET RECEIVED SHOWS CUT TUBING AT THE PUMP SEGMENT RESULTING FROM AN EXCESS AMOUNT OF GLUE AND STRESS APPLIED DURING THE ASSEMBLY PROCESS. 15 RETAINED SAMPLES FROM SAME LOT NUMBER REPORTED 1000079625 WERE ANALYZED. NO DEVIATION OR ANOMALY WAS IDENTIFIED. THE 15 RETAINED SAMPLES WERE FOUND CONFORMING TO MANUFACTURER SPECIFICATIONS. NO OTHER COMPLAINTS WERE REPORTED FOR THIS LOT NUMBER. THIS WAS AN ISOLATED EVENT.

    Description of Event or Problem · 1

    DURING THE LAST FEW MINUTES OF A DIALYSIS TREATMENT, THERE WAS AN EXTERNAL BLOOD LEAK ON THE BLOOD TUBING SET. TREATMENT WAS STOPPED AND THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT. THE BLOOD LOSS TO THE PATIENT WAS ESTIMATED TO BE BETWEEN 338 ML - 438 ML. THE PATIENT WAS NOT SYMPTOMATIC AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT WAS DISCHARGED HOME FOLLOWING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326998 CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. 1000079625

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other PHOENIX SN (B)(4), SWV 3.36.02, REVACLEAR