BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE

    MDR report key: 5103860 · Received September 25, 2015

    Report

    Report Number
    8030638-2015-00009
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    January 8, 2015
    Report Date
    September 25, 2015
    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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE BLOOD LINE WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION. HOWEVER, 15 RETAINED BLOOD TUBING SAMPLES FROM THE SAME LOT ( LOT 91000102643) WERE VISUALLY INSPECTED. NO FISSURES, CUTS, MACERATION, GAPS, VOIDS OR MISASSEMBLING WERE DETECTED. THE RETAINED SAMPLES WERE ALSO FUNCTIONAL AND LEAK TESTED AND NO FAILURES AND DEFECT WERE DETECTED. THE DHR FOR THIS LOT WAS REVIEWED AND THERE WERE NO MANUFACTURING ANOMALIES. IN ADDITION, THE COMPLAINT DATABASE WAS REVIEWED THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THE ROOT CAUSE OF THIS EVENT IS NOT KNOWN.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING A DIALYSIS TREATMENT WHICH INCLUDED A CARTRIDGE BLOOD LINE. AT THE END OF TREATMENT WHEN THE NURSE WAS RETURNING THE BLOOD IN THE EXTRACORPOREAL CIRCUIT, THE NURSE OBSERVED AN EXTERNAL BLOOD LEAK FROM THE SALINE PORT. THE BLOOD LOSS TO THE PATIENT WAS REPORTED TO BE "MINIMAL". THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS RETURNED TO THE PATIENT. THE PATIENT WAS NOT SYMPTOMATIC AND DID NOT REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635812 CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE 1000102643

    Patients

    Seq Age Sex Outcome Treatment
    1 Other