BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 560625 · Received December 13, 2004

    Report

    Report Number
    2134243-2004-00012
    Event Type
    Other
    Date Received
    December 13, 2004
    Date of Event
    November 8, 2004
    Report Date
    December 10, 2004
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AIR WAS INJECTED INTO THE PT DURING AN ANGIOGRAPHIC PROCEDURE. A HEALTH CARE PROFESSIONAL AT THE USER FACILITY REPORTED THAT, FOLLOWING THE AIR INJECTION, THERE DID NOT SEEM TO BE MAJOR COMPLICATIONS WITH THE PT. IT WAS REPORTED BY THE USER FACILITY THAT THEY HAD CONNECTED TO THE ACIST PRODUCT ANOTHER MFR'S PRODUCT THAT HAS NOT BEEN TESTED FOR COMPATIBILITY WITH THE ACIST PRODUCT, AND THAT THEY HAD COVERED PART OF THE SYSTEM WITH A STERILE DRAPE THAT COULD HAVE PREVENTED PROPER USER DILIGENCE IN DETECTING AND REMOVING AIR FROM THE SYSTEM. ADDITIONAL INFO WAS REQUESTED FROM THE USER FACILITY BY THE DISTRIBUTOR BUT AS OF THE DATE OF THIS REPORT THERE WAS NONE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other