BEUDAMED
    FDA Adverse Event Death Summary report: N

    8 PRONG CYCLER MANIFOLD

    MDR report key: 3040004 · Received April 3, 2013

    Report

    Report Number
    8030665-2013-00176
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 5, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K822549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WITH ADDITIONAL INFORMATION AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE MFR RECEIVED A USER FACILITY (B)(4) FROM FDA. THE USER FACILITY REPORTED "ONE BAG OF SOLUTION WAS INFUSING, THE OTHER THREE WERE CLAMPED PER RN. APPARENTLY, WITHIN A 1.5 HOUR PERIOD, ALL 4 BAGS WERE FOUND TO BE INFUSED. THE PT WAS UNRESPONSIVE, CPR AND CODE INITIATED AND THE PT IS CURRENTLY IN THE ICU. BOTH DIALYSIS RN AND FLOOR RN STATE ALL OF THE TUBES WERE CLAMPED EXCEPT THE ONE RUNNING. PT WAS IN THE BATHROOM FOR A PERIOD OF TIME PRIOR TO THIS. THE TUBES WERE REPORTED TO BE UNCLAMPED AFTER THE EVENT. UPON FOLLOW-UP WITH THE ACUTE PROGRAM MANAGER, THE MANAGER REPORTED THE PT EXPIRED ON (B)(6) 2013. THE MFR HAS CONTACTED THE RISK MANAGER (COMPLAINANT AND ACUTE PROGRAM MANAGER) AND REQUESTED MEDICAL RECORDS, ADDITIONAL INFORMATION AND SAMPLE RETURN FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137435 8 PRONG CYCLER MANIFOLD DIALYSIS TUBING SET FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death