BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 1013633 · Received March 13, 2008

    Report

    Report Number
    1518293-2008-00028
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM FIELD SERVICE REPORT: FIELD SERVICE ENGINEER CHECKED AND VERIFIED 'USED SYRINGE MESSAGE', 'FILL SEQUENCE' MESSAGES, AND 'CHECK FOR AIR' MESSAGE. PERFORMED OPERATIONAL CHECK OUT PROCEDURES ACCORDING TO SERVICE MANUAL. PERFORMED INJECTIONS AND VERIFIED INJECTOR OPERATION. INJECTION WORKING ACCORDING TO MFR SPECIFICATIONS AS PER ILLUMENA SERVICE MANUAL. INJECTOR SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    DURING THE COURSE OF RESPONDING TO A REQUEST FOR SERVICE, THE LIEBEL-FLARSHEIM FSE WAS ADVISED BY THE CUSTOMER OF A POSSIBLE AIR INJECTION. ELEVEN DAYS LATER: CUSTOMER REPORTS THE FOLLOWING, "A MALE HAVING A CARDIAC CATH TO R/O CAD. DURING THE PROCEDURE, THE PHYSICIAN PERFORMED AN INJECTION OF THE LEFT CORONARY ARTERY WITH THE ILLUMENA POWER INJECTOR, AND ALLEGEDLY AIR WAS INJECTED INSTEAD OF CONTRAST MEDIA. THE INJECTION PROTOCOL WAS SET FOR 4ML/SEC FOR A VOLUME OF 7ML WITH AN OPTIRAY 350 PREFILLED SYRINGE LOADED IN THE INJECTOR. CATHETER AND TUBING ATTACHED TO THE INJECTOR IS UNK. THE LOT NUMBER AND EXPIRATION DATE OF THE OPTIRAY CONTRAST MEDIA IS UNK AND ALL PRODUCT HAS BEEN DISCARDED. CUSTOMER STATES THAT THEY FEEL THERE WAS NO ERROR OR MALFUNCTION OF THE ILLUMENA POWER INJECTOR. PT WAS DISCHARGED HOME IN GOOD CONDITION AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT ILLUMENA POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. 900001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other