BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE WITH CEILING SUSPENSION

    MDR report key: 2598779 · Received May 30, 2012

    Report

    Report Number
    1518293-2012-00100
    Event Type
    Injury
    Date Received
    May 30, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 30, 2012
    Manufacturer
    LIEBEL-FLARSHEIM, CO.
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN AIR INJECTION OCCURRED DURING A PROCEDURE. COVIDIEN (B)(4) ARRIVED ON-SITE AND DISCOVERED THE CUSTOMER USED A 100 ML SALINE BAG TO FILL A SYRINGE WITH 50 ML OF SALINE FOR THREE INJECTIONS. THIS RESULTED IN THE LAST INJECTION, INJECTING AIR. PROPER OPERATION OF THE INJECTOR WAS VERIFIED BY RUNNING ALL MAINTENANCE CHECKS AND ELECTRICAL SAFETY TEST. THIS WAS CAUSED BY AN OPERATOR ERROR THERE WAS NO MALFUNCTION OF THE INJECTOR. NO FURTHER INVESTIGATION NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTS AIR INJECTION DURING CORONARY ANGIO TO RULE OUT CORONARY ARTERY DISEASES ON A FEMALE PT. AGE OF PT IS UNK. CUSTOMER REPORTS AIR WAS IDENTIFIED IN THE HEART FOLLOWING CONTRAST INJECTION. PT OBSERVED OVERNIGHT AND NOT TREATED. TEST CARRIED OUT OVER NIGHT IN THE HOSPITAL. PT WAS DISCHARGED NEXT DAY. COVIDIEN (B)(4) REPORTS: FOUND THAT ON TALKING TO STAFF AND CT SUPERINTENDENT THAT 3 INJECTIONS WITH SALINE CHASING WERE CARRIED OUT ONE AFTER THE OTHER. HOWEVER, B-SIDE FILLED WITH 1 X 100 ML SALINE BAG, AND THE AUTO FILL SET TO 50 ML, FOR ALL THREE INJECTIONS, AS A CONSEQUENCE, AIR INTRODUCED INTO THE LAST SYRINGE. CONTRAST TYPE: OPTIRAY 350 LOT 10I190SU. DOSE DELIVERED 95 ML. EQUIPMENT USED OPTIVANTAGE V8402 - (B)(4). CONSUMABLES: BAXTER SODIUM CHLORIDE 100 ML BAG, OPTIVANTAGE TRANSFER SET PART NUMBER 81055, LOT 1936641, EXP 01/2015, CT MULTIPACK PART 844021, LOT 1189156, EXP 07/2014, VENFRON - BRAUN NEEDLE SAFETY 180G - GREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIVANTAGE WITH CEILING SUSPENSION IZQ LIEBEL-FLARSHEIM, CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization OPTIVANTAGE TRANS SET: PART NO. (PN) 81055| LOT# 1936641, EXP: 01/2015.| EXP: 07/2014| VENFON-BRAUN SAFETY 18 G-GREEN| CT MULTIPACK: PN: 844021, LOT# 1189156