BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX SYSTEM

    MDR report key: 3693192 · Received March 21, 2014

    Report

    Report Number
    3003504604-2014-00002
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 21, 2014
    Manufacturer
    GAMBRO UF SOLUTIONS
    Product Code
    NQJ
    PMA / PMN Number
    K070512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE A1100 CONSOLE HAS NOT BEEN RETURNED FOR INVESTIGATION. A DEVICE HISTORY RECORD INVESTIGATION HAS DETERMINED THAT THE A1100 CONSOLE MEETS SPECIFICATION AND THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE DEVICE. A DEVICE HISTORY RECORD INVESTIGATION HAS DETERMINED THAT THE A1650 CIRCUIT MEETS SPECIFICATION. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Additional Manufacturer Narrative · 1

    THE COMPANY COMPLETED THE TECHNICAL INVESTIGATION ON THE CONSOLE AND CIRCUIT. THE CONSOLE TECHNICAL INVESTIGATION CONCLUDED THAT THERE WAS NO PRODUCT MALFUNCTION. THE DEVICE CONTINUES TO MEET ITS PERFORMANCE SPECIFICATIONS AND PERFORMS AS INTENDED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS DEVICE S/N. THE VISUAL INSPECTION WAS COMPLETED ON THE RETURNED CIRCUIT AND FOUND NO ANOMALIES. THE CIRCUIT DEVICE HISTORY REVIEW FOUND THAT THE PRODUCT MEETS SPECIFICATION. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS PRODUCT LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT WAS DIAGNOSED WITH HEMOLYSIS SEVERAL HOURS AFTER INITIATING ULTRAFILTRATION THERAPY. THE PATIENT WAS ANTICOAGULATED AND HAD AN ACUTE ONSET OF REDDISH BROWN URINE. THE THERAPY WAS DISCONTINUED AND THE PATIENT¿S SYMPTOMS RESOLVED THE SAME DAY. THE CAUSE OF THE HEMOLYSIS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170134 AQUADEX SYSTEM CATHETER, HEMODIALYSIS, NON-IMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL USE NQJ GAMBRO UF SOLUTIONS A1100 880

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other