BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX SYSTEM

    MDR report key: 3599422 · Received January 30, 2014

    Report

    Report Number
    3003504604-2013-00003
    Event Type
    Injury
    Date Received
    January 30, 2014
    Date of Event
    December 2, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GAMBRO UF SOLUTIONS
    Product Code
    NQJ
    PMA / PMN Number
    K070512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION HAS BEEN PROVIDED WITH REGARD TO THIS EVENT. IT WAS NOTED THAT THE ULTRAFILTRATE HAD A ¿PINK TINT¿ TO IT. ULTRAFILTRATE IS NORMALLY COLORLESS OR A LIGHT STRAW COLOR. PRESENCE OF EVEN A SMALL AMOUNT OF BLOOD GIVES THE ULTRAFILTRATE A BRIGHT RED COLOR. PINK TINT TO THE ULTRAFILTRATE COULD INDICATE THAT THERE IS SOME BLOOD LEAKAGE INTO THE ULTRAFILTRATE DUE TO A BROKEN FIBER IN THE FILTER. HOWEVER, IN TESTS PERFORMED TO DETERMINE THE DISCOLORATION DUE TO BLOOD LEAKAGE, THE RESULTS DEMONSTRATED THAT A SMALL AMOUNT OF BLOOD (1-2 ML) IN A LITER BAG OF FLUID WOULD RESULT IN A COLORMETRIC CHANGE OF MORE THAN JUST A TINT. THE CUSTOMER HAS NOT MADE THE SERIAL NUMBER OF THE CONSOLE KNOWN; THEREFORE, GAMBRO COULD NEITHER PERFORM A DEVICE HISTORY RECORD CHECK NOR A COMPLAINT FILE CHECK FOR THE CONSOLE. THE CUSTOMER HAS NOT MADE THE LOT NUMBER OF THE CIRCUIT KNOWN; THEREFORE, GAMBRO COULD NEITHER PERFORM A DEVICE HISTORY RECORD CHECK NOR A COMPLAINT HISTORY FILE CHECK FOR THE CIRCUIT. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY. DEVICE NOT RETURNED TO MFG; DEVICE SN AND LOT NUMBER HAVE NOT BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    CORRECTION: INITIALLY, THE EMDR MANUFACTURER REPORT NUMBER WAS SUBMITTED JANUARY 31, 2014 AS MANUFACTURER REPORT NUMBER: 3003504604-2013-00003. THE CORRECT MANUFACTURER REPORT NUMBER FOR THIS REPORT IS: 3003504604-2014-00001.

    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 SECONDARY TO UNEXPECTED WEIGHT GAIN AND SHORTNESS OF BREATH. FOUR DAYS AFTER AQUAPHERISIS WAS INITIATED, THE PATIENT¿S URINE TURNED A DARK MAROON COLOR AND THE ULTRAFILTRATE WAS PINK TINGED. THE PATIENT MAY HAVE DEVELOPED ACUTE KIDNEY INJURY. THE CLINICAL INVESTIGATION IS ONGOING. LIMITED INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66311 AQUADEX SYSTEM CATHETER, HEMODIALYSIS, NON-IMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL USE NQJ GAMBRO UF SOLUTIONS A1100 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention