BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 1617738 · Received February 17, 2010

    Report

    Report Number
    1518293-2010-00028
    Event Type
    Injury
    Date Received
    February 17, 2010
    Date of Event
    February 15, 2010
    Report Date
    February 15, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FACILITY PHARMACIST REPORTS VIA PHONE: A (B) (6) FEMALE, EXPERIENCED AN INFILTRATION OF OPTIRAY 350 CONTRAST MEDIA. NEED INFO ON TREATMENT OF THE INFILTRATION. NO OTHER INFO AVAILABLE AND TRANSFERRED TO ICU, NURSE CARING FOR PT. NURSE INDICATES THE PT SAYS, THERE IS NO PAIN AT THE SITE, BUT THE LEFT AC SITE IS RED AND SWOLLEN WITH BLISTERING. THEY HAVE APPLIED BACITRACIA TO THE SITE. PLASTIC SURGEON INSTRUCTED STAFF TO ELEVATE THE ARM AND TREAT WITH COLD COMPRESSES. THEY WILL VISUALLY EVALUATE 2/16. NURSE REPORTED THE PT WAS IN THE ICU FOR OTHER MEDICAL REASONS, NOT DUE TO THE INFILTRATION. NURSE HAS NO PROCEDURE INFO AND RECOMMENDED CALLING CT STAFF ON 2/16. ON 2/16: PHARMACIST REPORTS THE PLASTIC SURGEON HAS VISUALLY EXAMINED THE PT ARM. THE SWELLING AND BLISTERING HAS STARTED TO RESOLVE, THERE WILL NOT BE ANY SURGICAL INTERVENTION AT THIS TIME. ON 2/16: FOLLOW WITH CT STAFF FINDS, 65 Y/O, FEMALE, HAVING CT ABDOMEN WITH CONTRAST TO EVALUATE THE ABDOMINAL AORTA. IV ACCESS SITE WAS THE LEFT AC WITH A 20 GA GELCO PROTEC IV PLUS SAFETY IV CATHETER. OPTIVANTAGE DH INJECTOR WAS LOADED WITH AN OPTIRAY 350, 100ML PREFILLED SYRINGE (1333-83, LOT # T392C) FOR A SINGLE HEAD INJECTION PROCEDURE. SYRINGE WAS CONNECTED TO THE IV ACCESS WITH A (B) (4) COILED TUBING ((B) (4)). INJECTION PROTOCOL WAS 4ML/SEC FO R100ML VOLUME. INJECTION PERFORMED AND SCAN COMPLETED. TECHNOLOGIST NOTED IV INFILTRATION OF APPROXIMATELY 50 ML. PT DID NOT STATE ANY PAIN. DURING PM DISCUSSION WITH CT SUPERVISOR, PM ASKED THE STAFF IF THEY THOUGHT THE INJECTOR CONTRIBUTED TO THE CAUSE OF THE INFILTRATION. STAFF STATED, "NO". PM ASKED SUPERVISOR IF THEY WANTED LF SERVICE TO PROVIDE AN EVALUATION OF THE INJECTOR SYSTEM. STAFF STATED, "NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIVANTAGE DH POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO. OPTIVANTAGE DG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention