BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 319401 · Received March 7, 2001

    Report

    Report Number
    9615050-2001-00005
    Event Type
    Death
    Date Received
    March 7, 2001
    Date of Event
    February 3, 2001
    Report Date
    February 5, 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, "DURING A CODE SITUATION, THE CLAVE VALVE ON A PRIMARY SET WAS USED TO PUSH STAT DRUGS. THE VALVE WAS USED 3 TIMES THEN IT STUCK (INNER PLUG STAYED DOWN, IT DID NOT SPRING CLOSED). IV SITE WAS LOST. FLUIDS POURED FROM ADAPTER. IV SITE WAS RESTARTED AND A NEEDLE ADAPTER WAS USED ON THE VALVE." ADD'L INFO RECEIVED FROM THE REPORT SOURCE DURING PHONE CONVERSATION: PARAMEDICS WERE WITH THE PT AT PT'S HOME. THEY STARTED THE IV WITH THE TUBING SET. THE PT ARRESTED, THE PARAMEDICS ESTABLISHED A CARDIAC RHYTHM AND TRANSPORTED THE PT TO THE HOSP E.R. THE PT ARRESTED IN THE E.R. AND STAFF ESTABLISHED A CARDIAC RHYTHM. IT IS UNKNOWN TO THE REPORTER THE SEQUENCE OF WHEN, WHERE AND WHO GAVE THE EPINEPHRINE AND ATROPINE, BUT THE EMERGENT DRUGS HAD BEEN GIVEN VIA THE CLAVE VALVE WITHOUT PROBLEM. ON THE LAST EPINEPHRINE ADMINISTRATION ATTEMPT, THE SYRINGE WOULDN'T LOCK. IN TRYING TO GIVE THE EPINEPHRINE, IT WOULD LEAK AROUND THE TOP OF THE CLAVE VALVE. THE STAFF WAS UNABLE TO ADMINISTER THE EPHINEPHRINE. REPORTER STATES THE CLAVE VALVE LOOKS RECESSED ABOUT 1/4 OF AN INCH. THE IV SITE WAS LOST (REASON UNKNOWN) AND WAS RESTARTED. MORE UNSPECIFIED MEDICATIONS WERE GIVEN AND A CARDIAC RHYTHM WAS ESTABLISHED FOR A SHORT WHILE. EVENTUALLY THE PT EXPIRED. THE STAFF DOES NOT FEEL THE CLAVE VALVE INCIDENT MADE A DIFFERENCE IN THE PT'S OUTCOME. THE INCIDENT SLIGHTLY IMPEDED THE RESUSCITATION PROCESS, BUT IT DID NOT IMPACT THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9684 PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 70-009-5H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| O EMERGENT DRUGS USED WERE MFG BY INTERNATIONAL| MEDICATION SYSTEMS (IMS).