BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL

    MDR report key: 356747 · Received October 19, 2001

    Report

    Report Number
    1018381-2001-00091
    Event Type
    Death
    Date Received
    October 19, 2001
    Date of Event
    September 19, 2001
    Report Date
    September 19, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D OF AN INABILITY TO DELIVER EMERGENT DRUGS DURING A CODE SITUATION. THE CUSTOMER STATES THAT THE PT HAD A DOUBLE LUMEN CENTRAL LINE. THE TUBING SET WITH A CLAVE VALVE WAS CONNECTED TO ONE OF THE LUMENS AND WAS INFUSING AN UNSPECIFIED IV FLUID. A STAND ALONE CLAVE VALVE WAS CONNECTED TO THE OTHER PORT WITHOUT IV FLUID INFUSING. THE PT ARRESTED AND DURING THE CODE IT WAS REPORTED THAT TWO IMS SYRINGES, EPINEPHRINE AND ATROPINE, WERE ATTEMPTED TO BE ADMINISTERED VIA THE CLAVE VALVE ON THE TUBING SET. NEITHER OF THE DRUGS COULD BE ADMINISTERED VIA THE CLAVE VALVE. WHEN THE SYRINGES WERE REMOVED FROM THE CLAVE PORT, IT WAS REPORTED THAT IV FLUID LEAKED FROM THE CLAVE. IT WAS OBSERVED THAT THE CENTER OF THE CLAVE HAD STUCK DOWN. THE TUBING SET WAS REMOVED FROM THE CENTRAL LINE PORT AND THE DRUGS WERE ADMINISTERED FROM THE HUB OF THE SYRINGE TO THE HUB OF THE PORT. THE MEDICATIONS WERE NOT ATTEMPTED TO BE DELIVERED VIA THE STAND ALONE CLAVE VALVE. THE PT DID NOT SURVIVE THE CODE. THE DELAY OF DELIVERING THE EMERGENT DRUGS WAS A SHORT AMOUNT OF TIME AND DID NOT IMPACT THE PT OUTCOME. THE RPTR STATED THAT THE PT WOULD NOT HAVE SURVIVED THE ARREST. ADD'L PT INFO WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47021 PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL ADMINISTRATION SET FPA ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death IMS SYRINGES, EPINEPHRINE AND ATROPINE.