BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 319415 · Received March 7, 2001

    Report

    Report Number
    1018381-2001-00015
    Event Type
    Death
    Date Received
    March 7, 2001
    Date of Event
    February 12, 2001
    Report Date
    February 13, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RECEIVED VOLUNTARY MEDWATCH FROM CUSTOMER WHICH STATES, "UNRESPONSIVE PT IN V-FIB, PICKED UP BY PARAMEDICS. DEFIBRILLATED TWO TIMES, THEN RHYTHM BECAME ASYSTOLE. ENDOTRACHEAL TUBE WAS PLACED AND 2MG OF EPINEPHRINE GIVEN VIA THE E.T.T. CPR CONTINUED AND THE PT REMAINED IN ASYSTOLE. AN IV SITE WAS INITIATED AND 1MG ATROPINE WAS ATTEMPTED VIA THE LOWER CLAVE PORT, BUT WOULDN'T RUN. 2MG EPINEPHRINE WAS GIVEN VIA THE E.T.T. ARRIVED IN E.R., STILL IN ASYSTOLE WITH CPR CONTINUING. UNSPECIFIED MEDICATIONS GIVEN. THE PT EXPIRED. THE EMT STATED THAT THIS DID NOT DIRECTLY AFFECT THE PT'S CARE BECAUSE THE ENDOTRACHEAL ROUTE WAS AVAILABLE AND USED." ADD'L INFO RECEIVED FROM THE CUSTOMER DURING PHONE CONVERSTATION: REPORTER STATES THE EVENT DESCRIBED ON THE USER FACILITY MEDWATCH ARE NOT IN THE CORRECT ORDER. THE PARAMEDICS WERE UNABLE TO ESTABLISH AN IV SITE IN THE FIELD. AFTER THE 2MG OF EPINEPHRINE WERE GIVEN VIA THE ETT, THE PT WAS TRANSPORTED TO THE E.R., WHERE A SURGEON ESTABLISHED THE JUGULAR IV AND THE TUBING SET WAS HUNG. THE ATROPINE COULD NOT BE ADMINISTERED VIA THE LOWER CLAVE PORT. ADD'L INFO ABOUT THE OCCURRENCE WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9668 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 39 YR Life Threatening| O EMERGENT DRUGS WERE MFG BY INTERNATIONAL| MEDICATION SYSTEMS (IMS).