BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 359335 · Received October 30, 2001

    Report

    Report Number
    9615050-2001-00029
    Event Type
    Death
    Date Received
    October 30, 2001
    Date of Event
    September 25, 2001
    Report Date
    September 25, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D OF INABILITY TO ADMINISTER EMERGENCY MEDICATIONS THROUGH THE CLAVE VALVE. A PT WAS BEING TREATED IN THE EMERGENCY ROOM FOR A HEART ATTACK AND IN FULL CARDIAC ARREST. THE RPTR STATES THEIR STOCK DRUGS INCLUDED ABBOJECT SYRINGES WITH NEEDLES, WHICH WERE USED TO ATTEMPT TO ACCESS A CLAVE PORT ON A TUBING SET. THE RPTR STATED THAT WAS UNABLE TO PUSH THE DRUGS ATROPINE AND EPINEPHRINE THROUGH THE NEEDLELESS SYSTEM. THEREFORE, RPTR PUNCTURED THE TUBING TO DELIVER THE DRUGS. RPTR REPORTED THAT RPTR TOOK THE DRUGS OUT OF THE SYRINGES AND PLACED THEM INTO ANOTHER SYRINGE TO DELIVER THE DRUGS THROUGH THE TUBING. RPTR HAD TO CHANGE THE TUBING BECAUSE OF THE PUNCTURE HOLES AND STATED RPTR FINALLY "CUT THE CLAVE OFF" BELOW THE BONDED AREA. RPTR THEN APPLIED A HEPLOCK-LIKE ADAPTER. RPTR STATED "IT IS NOT LIKELY THAT THE DELAY CAUSED THE DEATH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48561 PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 780325H

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death