BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8FR - 30 CC FOS

    MDR report key: 2427264 · Received January 5, 2012

    Report

    Report Number
    1219856-2011-00490
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 22, 2011
    Report Date
    January 5, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER CALLED TO TROUBLESHOOT THE (INTRA-AORTIC BALLOON PUMP, SERIAL NUMBER (B)(4)) "HE LOSS 2" ALARMS. ACCORDING TO THE CALLER "IMMEDIATELY POST INSERTION, IN THE OPERATING ROOM THE ALARMS STARTED. THE POSITION IN THE CATHETER WAS VERIFIED VIA TEE. THE PT IS (B)(6), A 30 CC IAB WAS INSERTED VIA THE FEMORAL ARTERY." THEY HAVE ALREADY ATTEMPTED DIFFERENT TRIGGER OPTIONS IN OPERATOR MODE, DECREASING VOLUME TO 25 CC FIRST, THEN 20 CC. THE ALARM HAS CONTINUED. THE CLINICAL SUPPORT SPECIALIST (CSS) INSTRUCTED THE USER TO DECREASE THE RATIO TO 1:2, THE ALARM AGAIN OCCURRED. THE CSS ASKED THEM TO VERIFY AGAIN THAT THERE WAS NO BLOOD PRESENT IN THE TUBING, NONE WAS NOTED. THE CSS WALKED THE USER THROUGH PERFORMING A LEAK TEST. DURING THIS TEST NO LOSS OF VOLUME WAS NOTED, THE CATHETER FAILED THE TEST. THE CSS EXPLAINED TO THE USER "THE TEST RESULTS ISOLATED THE PROBLEM TO THE CATHETER. IT COULD POSSIBLY BE DUE TO A TORTUOUS INSERTION OR INTERNAL KINK, OR IT COULD ACTUALLY BE AN ABRASION IN THE IAB FROM PLAQUE." THE USER RELAYED THE MESSAGE TO THE DR ALONG WITH OUR RECOMMENDATION TO REMOVE THE CATHETER. THE MD AGREED. AT 1709, THE CSS SPOKE TO THE USER AGAIN AND THE REMOVAL AND REINSERTION WENT WELL; THERE HAVE BEEN NO ALARMS SINCE THE REINSERTION. THE PT IS STABLE AND SUPPORTED ON THE PUMP. THERE WAS A DELAY IN IABP THERAPY FOR THE TIME FRAME REQUIRED TO REMOVE AND THEN INSERT ANOTHER IAB VIA THE SAME INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP