BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT PLUM SET

    MDR report key: 315984 · Received February 13, 2001

    Report

    Report Number
    MW1021054
    Event Type
    Death
    Date Received
    February 13, 2001
    Date of Event
    February 12, 2001
    Report Date
    February 13, 2001
    Manufacturer
    *
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    UNRESPONSIVE PT IN V-FIB PICKED UP BY PARAMEDICS. DEFIBRILLATED X 2 (ASYSTOLE) ENDOTRACHEAL INTUBATION. 2MG EPI 1: 10,000 GIVEN VIA ENDOTRACHEAL TUBE. IV INITIATED W/18G TO LEFT EXTERNAL JUGULAR (STILL ASYSTOLE). CPR CONTINUED. ADMINISTERED 1 MG ATROPINE IV PUSH WITH DIFFICULTY. ATROPINE SYRINGE ATTEMPTED THRU LOWER CLAVE PORT - WOULD NOT RUN. USED AS NEEDLE - LESS (PROTECTED NEEDLE REMOVED). ADMINISTERED 2MG EPI 1:10,000 VIA ENDOTRACHEAL ARRIVED AT ER (IN ASYSTOLE). LABATOLOL AND QUESTIONABLE ADMINISTRATION, CPR CONTINUED. PT EXPIRED. EMT STATED THAT THIS DID NOT DIRECTLY AFFECT THIS PT'S CARE BECAUSE ENDOTRACHEAL ROUTE WAS AVAILABLE AND USED. NOTE: PHARMACIST WAS ABLE TO RECONSTRUCT VALVE "MISFUNCTION" X3 BY CONNECTING AN IMS (INTERNATIONAL MEDICATION SYSTEMS) MIN-I-JECT TO AN ABBOTT #12094 MACROBORE 7" EXTENSION SET WITH CLAVE VALVE. THE IMS SYRINGES APPEAR INCOMPATIBLE WITH THE CLAVE VALVE IN THAT CONNECTING THE TWO CAUSES VALVE "MISFUNCTION". THE VALVE BARELY FLOWS (DRIPS ONLY IF PUT EXCESSIVE PRESSURE ON PLUNGER OF SYRINGE). REMOVAL OF THE SYRINGE LEAVES THE INNER PART OF VALVE DEPRESSED - DOES NOT POP BACK UP LIKE IT SHOULD. IF YOU ATTACHED AN ALARIS SMART SITE VALVE TO THE CLAVE VALVE, THE CLAVE FUNCTIONS PERFECTLY AND FLOW IS FINE. PROBLEM REPRODUCED WITH ABBOTT #12094 7" EXT SET W/CLAVE, SO THIS IS NOT A LOT # PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5474 ABBOTT PLUM SET IV ADMIN SET W/CLAVE VALVE FPA * * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death ATROPINE SULFATE INJECTION 1MG/10ML 1MG/10ML| LOT A5083E9 EXP DATE 4/02.