BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 2423797 · Received December 22, 2011

    Report

    Report Number
    1219856-2011-00477
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    November 29, 2011
    Report Date
    December 21, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 CATH LAB, THE MD INSERTED THE SHEATH AND THEN THE INTRA-AORTIC BALLOON (IAB) VIA THE PATIENT'S RIGHT FEMORAL ARTERY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARDIAC CARE UNIT (ICCU) AND AFTER SOME HOURS, THE PUMP ALARMED "HELIUM LEAKAGE." THE BALLOON PRESSURE WAVEFORM (BWP) CURVE WAS NORMAL; ALSO THE AORTIC FLOW WAVE WAS NORMAL. THE ALARM KEPT ON COMING UP ON THE DISPLAY. A NEW INTRA-AORTIC BALLOON PUMP (IABP) WAS CONNECTED TO THE IAB AND THE SECOND PUMP ALSO DISPLAYED THE SAME ALARM. AFTER CONSULTING THE CARDIOLOGIST, THE IAB WAS REMOVED. ANOTHER IAB WAS NOT INSERTED BECAUSE THE PATIENT DID NOT NEED IABP SUPPORT. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AND REPORTED AS "REMOVAL OF THE IAB." THE IABP THERAPY WAS DELAYED/INTERRUPTED BUT THERE WAS NO HARM TO THE PATIENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT OUTCOME IS LISTED AS NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 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