BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1203525 · Received October 17, 2008

    Report

    Report Number
    1219856-2008-00485
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ARROW INTL. INC.
    Product Code
    DSP
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CALL WAS PLACED TO THE HOT LINE STATING THAT THE INTRA-AORTIC BALLOON (IAB) WAS PLACED IN 2008. THE FOLLOWING DAY, THE RN REPORTED THAT THERE WAS A LOT OF BLOOD COMING BACK IN THE DRIVE LINE. AS A RESULT, THE IAB WAS REMOVED AND ANOTHER IAB WAS INSERTED. REFERENCE MEDWATCH 1219856-2008-00482 FOR SECOND EVENT INVOLVING SAME PATIENT AND THE INTRA-AORTIC BALLOON PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL. INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR