BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE, ROLL AROUND INJ SYSTEM

    MDR report key: 3140043 · Received May 29, 2013

    Report

    Report Number
    1518293-2013-00124
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 29, 2013
    Manufacturer
    LIEBEL - FLARSHEIM CO.
    Product Code
    DXT
    PMA / PMN Number
    KO73592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) AND CONFIRMED THE ERROR IN THE ERROR LOG. FSE CHECK THE INJECTOR CABLES AND POWERHEAD AND FOUND NO PROBLEMS, AND WAS UNABLE TO DUPLICATE THE ERROR. FSE TESTED THE INJECTOR PER SERVICE CHECKLIST, AND THE INJECTOR PASSED CHECKOUT PROCEDURES AND RETURNED TO FULL SERVICE. PRODUCT MONITORING NOTIFIED THIS MANUFACTURER OF THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013: THE MRI TECH STARTED AN INJECTION. THE INJECTOR DISPLAYED AND ERROR #1. HE TURNED THE INJECTOR OFF THEN BACK ON. HE STARTED THE INJECTION. THE INJECTOR DISPLAYED AND ERROR #1. HE TURNED THE INJECTOR OFF. HE WENT INTO THE ROOM AND DISCONNECTED THE TUBING FROM THE PATIENT. WHEN HE DISCONNECTED THE TUBING, HE GOT SPRAYED IN THE EYES WITH CONTRAST. HE FLUSHED HIS EYES. HE WENT TO THE OCCUPATIONAL HEALTH DEPARTMENT. THEY FLUSHED HIS EYES AGAIN. HE THEN WENT TO THE EYE DOCTOR FOR EVALUATION. THEY SAID HE WAS OKAY. I ASKED HIM HOW HE WAS FEELING AND SAID HE WAS OKAY. AT THE TIME OF THE EVENT, HE WAS USING A NON-COVIDIEN SYRINGE KIT WITH A COVIDIEN 50ML PREFILLED SALINE SYRINGE. THE KIT IS FROM THE SHENZHEN ANT HI-TECH INDUSTRIAL CO, AND THE INFORMATION WAS FORWARDED TO MANUFACTURER. THE KIT INCLUDES A 60ML SYRINGE, 250CM Y-TUBING AND A LONG SPIKE. THE KIT NUMBER IS 200301A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234443 ELITE, ROLL AROUND INJ SYSTEM DXT LIEBEL - FLARSHEIM CO. ELITE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COVIDIEN 50ML PREFILLED SYRINGE| NON-CONVIDIEN SYRINGE KIT