BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: THERMISTOR 7 110CM

    MDR report key: 4152496 · Received October 6, 2014

    Report

    Report Number
    3010532612-2014-00025
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYG
    PMA / PMN Number
    K823433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE OPERATING ROOM DURING USE OF AN AI-07367. THE USER EXPERIENCED CONNECTION DIFFICULTY AMONG THE LUMENS. AS A RESULT, THE CATHETER WAS REMOVED. A NEW CATHETER KIT WAS OPENED AND USED SUCCESSFULLY. THE PROCEDURE WENT ON AS PLANNED. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PT NOTED. THE PT OUTCOME IS OK. ADDITIONAL INFO CONFIRMED THAT TH EVENT WAS AN INTERLUMEN PROBLEM. THE EVENT OCCURRED DURING INFLATION OF THE CUFF WHEN THE LUMENS WERE CONNECTED TOGETHER. WHEN ATTEMPTING TO INFLATE THE BALLOON THE AIR ESCAPED THROUGH ANOTHER LUMEN. THE INSERTION SITES ARE UNK. THE SECOND KIT WAS ALSO AN ARROW AI-07367. IT IS UNK HOW LONG THE DELAY OR INTERRUPTION IN THERAPY WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622221 CATH PKGD: THERMISTOR 7 110CM BALLOON THERMODILUTION CATHETER DYG ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1