BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 30 CC

    MDR report key: 1230394 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00498
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL INC
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. A SHEATH WAS INSERTED VIA THE RIGHT GROIN AND THEN THE IAB WAS INSERTED. SOON AFTER INSERTION THE PUMP, A DATASCOPE CS100, ALARMED AND BLOOD WAS FOUND IN THE GAS LINE. AS A RESULT, THE IAB WAS REMOVED AND ANOTHER IAB WAS INSERTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7.5 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL INC MF7044421

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR DATASCOPE CS100 BALLOON PUMP