BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX SYSTEM

    MDR report key: 4283341 · Received November 20, 2014

    Report

    Report Number
    3003504604-2014-00004
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    August 19, 2014
    Report Date
    November 20, 2014
    Manufacturer
    CATHETER, HEMODIALYSIS, NON-IMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL USE
    Product Code
    NQJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: LIMITED INFORMATION HAS BEEN PROVIDED WITH REGARD TO THIS EVENT. A DEVICE HISTORY RECORD INVESTIGATION FOR A1100 CONSOLE S/N (B)(4) DETERMINED THAT THE CONSOLE MEETS SPECIFICATION. THE LOT NUMBER OF THE CIRCUIT IS CURRENTLY UNKNOWN; THEREFORE, GAMBRO COULD NEITHER PERFORM A DEVICE HISTORY RECORD INVESTIGATION NOR A COMPLAINT HISTORY FILE CHECK FOR THE CIRCUIT.

    Description of Event or Problem · 1

    GAMBRO RECEIVED A VOLUNTARY MEDWATCH REPORT THAT STATED A PATIENT WITH A COMPLEX MEDICAL HISTORY WAS ADMITTED TO THE HOSPITAL FOR ACUTE SYSTOLIC HEART FAILURE. FOUR DAYS AFTER AQUAPHERISIS WAS INITIATED, THE PATIENT'S URINE TURNED A DARK RED BROWN COLOR AND THE ULTRAFILTRATE WAS PINK TINGED. THE MEDICAL TEAM DISCONTINUED AQUAPHERISIS AND STARTED THE PATIENT ON DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753674 AQUADEX SYSTEM NQJ CATHETER, HEMODIALYSIS, NON-IMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL USE A1100/A1650 246/UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention