BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 30 CC

    MDR report key: 2002514 · Received January 28, 2011

    Report

    Report Number
    1219856-2011-00037
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K970689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO THE PATIENTS' RIGHT FEMORAL ARTERY. IT WAS REPORTED BY THE PERFUSIONIST THAT FIVE MINUTES AFTER THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY BEGAN, BLOOD WAS NOTICED AT THE BIFURCATION. THE TUBING WAS CLAMPED IMMEDIATELY. THE PUMP (B)(4) DID NOT ALARM AND NO STRIPS WERE GENERATED. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE IAB WAS REMOVED AND REPLACED. THE DELAY IN IABP THERAPY IS LISTED AS FIVE MINUTES. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT OUTCOME IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR ANTICOAGULANT| PLAVIX| EPARINE| IABP