BEUDAMED
    FDA Adverse Event Summary report: N

    ADVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 2250766 · Received September 12, 2011

    Report

    Report Number
    2250766
    Date Received
    September 12, 2011
    Date of Event
    July 25, 2011
    Report Date
    September 8, 2011
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING EMERGENCY PTCA WITH STENT FOR CHEST PAIN AND ACUTE MYOCARDIAL INFARCTION (STEMI). APPROXIMATELY ONE HOUR INTO THE PROCEDURE, THE PATIENT SUDDENLY BECAME UNRESPONSIVE AND BEGAN A "SNORING" TYPE RESPIRATION AND HAD VENTRICULAR TACHYCARDIA PER THE MONITOR. A CODE WAS CALLED; HOWEVER, IT WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. CATH REPORT INDICATED PATIENT HAD TWO OCCLUSIONS OF THE LAD, PROXIMAL 80% STENOSIS THROMBUS (WHICH WAS STENTED SUCCESSFULLY) AND THEN DISTALLY HAD A 100% OCCLUSION. PROXIMATE TO THIS CASE THE FOLLOWING WAS REPORTED - WHEN THE MACHINE WAS ACTIVATED AND PROGRAMED TO "FILL" THE SYRINGE, THE PISTON ON THE INJECTOR BEGAN TO WITHDRAW RESULTING IN ONE SIDE OF THE RUBBER PLUNGER TO NOT COMPLETELY ENGAGE WITH THE PISTON. A "GRINDING NOISE" WAS ALSO AUDIBLY HEARD BY THE STAFF. MEDRAD CHANGED OUT THE INJECTOR HEAD ON THIS DEVICE A FEW DAYS AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA FLUID MANAGEMENT SYSTEM INJECTOR, CONTRAST DXT MEDRAD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR