BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 4580922 · Received March 5, 2015

    Report

    Report Number
    1219856-2015-00046
    Event Type
    Injury
    Date Received
    March 5, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 18, 2015
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REF MDR # 1219856-2015-00047 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE EVENT INVOLVED A (B)(6) FEMALE PT, (B)(6) WHILE IN THE OPERATING ROOM DURING USE. THE MD INSERTED THE SECOND IAB-05840-LWS AND THE SAME RESULT OCCURRED. THE INTRA-AORTIC BALLOON PUMP (AUTOCAT2WAVE) ALARMED 'HELIUM LEAK.' AS A RESULT THE IAB WAS REMOVED, WHICH CAUSED HARM TO THE PT. THE PT WAS TREATED WITH ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION). THERE WAS NO REPORT OF PT DEATH. THE PT OUTCOME IS UNK. IT WAS STATED THEY ALWAYS CHECK THE PLACEMENT OF THE IAB; NO BLIND INSERTION AND CHECKED RELATION OF PT TO IAB. IT WAS NOTED THAT THE IABP'S USED WERE AUTOCAT2WAVE SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152876 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBEROPTIC SYS DSP ARROW INTL., INC. 18F13G0011

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other