BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX SYSTEM

    MDR report key: 3288190 · Received August 14, 2013

    Report

    Report Number
    3003504604-2013-00002
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    July 13, 2013
    Report Date
    July 18, 2013
    Manufacturer
    GAMBRO UF SOLUTIONS
    Product Code
    NQJ
    PMA / PMN Number
    K070512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE A1100 AQUADEX CONSOLE WILL NOT BE RETURNED FOR EVALUATION BECAUSE THERE ARE NO DATA THAT SUGGESTS AN A1100 AQUADEX SYSTEM MALFUNCTION OCCURRED. AN A1100 AQUADEX CONSOLE DEVICE HISTORY RECORD INVESTIGATION HAS DETERMINED THAT THE A1100 AQUADEX CONSOLE MEETS SPECIFICATION AND THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE DEVICE. THE A1100 AQUADEX CONSOLE OPERATED AS INTENDED; THERE WAS NO MALFUNCTION OR ALLEGED DEVICE MALFUNCTION. THE EVENT WAS DIRECTLY RELATED TO THE HEALTHCARE PROFESSIONAL'S CONNECTION OF THE B BRAUN 50 ML PERFUSOR SYRINGE IN THE B BRAUN FM PERFUSOR PUMP PERFUSER; THIS EVENT IS CONSIDERED USER ERROR.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING AQUAPHERISIS TREATMENT ON AN AQUADEX MACHINE IN CONJUNCTION WITH A B BRAUN FM PERFUSOR PUMP AND A B BRAUN 50 ML PERFUSOR SYRINGE USED FOR AN ONGOING INFUSION OF HEPARIN. THE PERFUSOR PUMP WAS CONNECTED TO THE WITHDRAW ACCESS PORT ON THE EXTRACORPOREAL CIRCUIT. THE PERFUSOR PUMP GENERATED AN ALARM AT WHICH TIME THE USER FOUND THE SYRINGE OF HEPARIN (CONTAINING APPROXIMATELY 20 ML HEPARIN) EMPTIED AND 10,000 IU OF HEPARIN WAS ADMINISTERED TO THE PATIENT INSTEAD OF THE INTENDED 1,000 IU/HOURLY INFUSION. ACCORDING TO THE HEALTHCARE PROVIDER, THE PERFUSOR SYRINGE WAS NOT PROPERLY SEATED AND LOCKED IN THE PERFUSOR PUMP WHICH RESULTED IN THE UNINTENDED EMPTYING OF THE HEPARIN SYRINGE. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF UNINTENDED HEPARIN DOSAGE. THE PATIENT WAS ADMINISTERED 3500 IU OF PROTAMINE SULFATE TO REVERSE THE ANTICOAGULANT EFFECT OF THE HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390808 AQUADEX SYSTEM CATHETER, HEMODIALYSIS, NON-IMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL USE NQJ GAMBRO UF SOLUTIONS A1100-03 4057

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Required Intervention B BRAUN FM PERFUSOR, B BRAUN 50 ML PERFUSOR SYRG