BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH DEMO SALE

    MDR report key: 1210198 · Received October 23, 2008

    Report

    Report Number
    1518293-2008-00320
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MFG REPORT: FIELD SERVICE ENGINEER CHECKED OUT THE INJECTOR PER SERVICE MANUAL. INJECTOR SYSTEM OPERATING PER MANUFACTURES SPECIFICATIONS. INJECTOR RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A F WAS HAVING A CT PROCEDURE TO RULE OUT PULMONARY EMBOLISM. AT THE END OF THE PROCEDURE THEY NOTICED A SMALL INFILTRATION ABOUT THE DIAMETER SIZE OF A NICKEL AND 2 MM IN HEIGHT. CUSTOMER DID REPORT THEY HAD PROBLEMS WITH THE 22 GA IVP CATHETER BEFORE THE PROCEDURE AND BELIEVES THIS WAS THE PROBLEM AND NOT THE INJECTOR. PRESSURE WAS APPLIED TO THE SITE ALONG WITH A WARM COMPRESS. THE PT INFILTRATION SITE LOOKED FINE AND SHE WAS TRANSFER BACK TO HER ROOM. THE PROTOCOL USED FOR THIS INJECTION WAS FOR 3ML/SEC FOR A TOTAL VOLUME OF 100ML OF VISIPAQUE 320 CONTRAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIVANTAGE DH DEMO SALE CT POWER INJECTOR IZQ LIEBEL-FLARSHEIM CO. DS844001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention