BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 2633709 · Received June 20, 2012

    Report

    Report Number
    2134243-2012-00009
    Event Type
    Death
    Date Received
    June 20, 2012
    Date of Event
    May 18, 2012
    Report Date
    June 21, 2012
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM, MODEL E2000 VOYAGER, WAS RETURNED TO ACIST ON (B)(4) 2012 FOR TESTING. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION BASED ON THE DATA FROM THE ANALYSIS OF THE INJECTOR. THE CONSUMABLE KITS USED DURING THE EVENT WERE DISCARDED BY THE USER FACILITY; NO ANALYSIS COULD BE MADE OF THOSE ITEMS. THERE ARE NO IMAGES AVAILABLE TO DETERMINE IF AIR WAS INJECTED AND THE AMOUNT OF AIR, THEREFORE, NO DEFINITE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. ACIST'S RISK MANAGEMENT HAS APPROPRIATE RISK MITIGATIONS IN PLACE FOR POTENTIAL AIR EMBOLISM DUE TO USER ERROR, INCLUDING LABELING DESCRIBING AIR BUBBLE PRECAUTIONS AND THE USER MANUAL WHICH GUIDES THE USER THROUGH THE SET-UP AND PURGE OF THE INJECTOR SYSTEM. THIS REPORT IS CLOSED.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTED: DURING A DIAGNOSTIC CATHETERIZATION, IT WAS SUSPECTED THAT AIR HAD BEEN INJECTED UPON THE FIRST INJECTION OF CONTRAST MEDIA. THE AIR WAS NOT VISIBLE ON THE IMAGES; THE FIRST INJECTION WAS A TEST INJECTION WITH NO IMAGE TAKEN. THE PT EXPERIENCED ST SEGMENT ELEVATION, VENTRICULAR FIBRILLATION, AND BLOOD PRESSURE OF LESS THAN 90 MMGH SYSTOLIC. CARDIAC ARREST OCCURRED AND THE PT EXPIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC CONTRAST INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. E2000 VOYAGER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death ASPIRIN (ACETYLSALICYLIC ACID)| CATHETER - 4FR LEFT| BETA BLOCKERS| CLOPIDOGREL| INTERNAL AUTOMATIC DEFIBRILLATOR| ACE INHIBITOR (ANGIOTENSIN II)