BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (BASIC) SYSTEM CT9000

    MDR report key: 1053304 · Received May 16, 2008

    Report

    Report Number
    1518293-2008-00091
    Event Type
    Injury
    Date Received
    May 16, 2008
    Report Date
    May 26, 2005
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MFG REPORT: FSE VERIFIED FLOW & PRESSURE CHECKS, LIMITING AND PROPER OPERATION. UNABLE TO GENERATE AN EXTRAVASATION SCENARIO - VERIFIED OPERATIONS WITH BIOMEDS PRESENT. INJECTOR RETURNED TO FULL SVC BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS INFILTRATION: A MALE SEEN IN ER FOR ABDOMINAL PAIN FOR 48 HRS. 22GA ANGIOCATH IV STARTED IN THE RIGHT AC. CT OF ABDOMEN WITH CONTRAST ORDERED. AT 1.8CC RATE FOR 120CC VOLUME INJECTION OF OPTIRAY 300 INJECTED. PT DID NOT COMPLAIN OF PAIN DURING PROCEDURE. ER RN, IN ATTENDANCE OF CT NOTED SOFT EDEMA POST CT AT INJECTION SITE AND THAT THE RIGHT ARM AT 27CM JUST ABOVE THE ELBOW AND THE LEFT AT 22CM JUST ABOVE THE ELBOW. ER RN WAS ABLE TO WITHDRAW 4CC OF CONTRAST MEDIA FROM INJECTION SITE. WARM COMPRESS WAS APPLIED TO INJECTION SITE. PT WAS ADMITTED, NOT BECAUSE OF INFILTRATION, BUT ADMITTING DIAGNOSIS WERE; ACUTE FEVER, LEUKOCYTOSIS, ABDOMINAL PAIN AND IV CONTRAST INFILTRATION. PT WAS DISCHARGED NEXT DAY. AREA NOT PAINFUL, SWELLING GREATLY REDUCED. NOT A PROBLEM (PER DISCHARGING PHYSICIAN NOTES). CUSTOMER REPORTS NO WAY TO DETERMINE AMOUNT OF EXTRAVASATION BECAUSE THE PT DID NOT COMPLAIN OF PAIN DURING CT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (BASIC) SYSTEM CT9000 CT POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention