BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 2243867 · Received August 24, 2011

    Report

    Report Number
    1219856-2011-00301
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 19, 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE THEATRE, PRIOR TO SURGERY, THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE TEFLON SHEATH VIA RIGHT FEMORAL ARTERY WITH SUCCESS ON (B)(6) 2011 AND PT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. ON (B)(6) 2011, THE PT WAS TRANSFERRED TO THE THEATRE FOR SURGERY, THE PUMP STARTED GIVING HELIUM LOSS ALARMS. NO REASON WAS FOUND FOR THE ALARMS, NO BLOOD IN THE TUBING, ALL CONNECTIONS SEEMED FINE, THE PUMP WAS TURNED OFF DURING THE OPERATION AND THE HELIUM BOTTLE AND PUMP WERE CHECKED FOR ANY LEAKS AND FOUND NONE. THE MD MADE A DECISION TO REMOVE THE BALLOON DURING THE OPERATION AND INSERT A NEW ONE RATHER THAN RISK THE CHANCE OF A SMALL RUPTURE. AS A RESULT, THE IAB AND SHEATH WERE REMOVED TOGETHER. A NEW KIT WAS OPENED AND THE NEW IAB WAS INSERTED THROUGH THE TEFLON SHEATH VIA THE SAME INSERTION SITE. THERE WAS NO THERAPY DELAY OR INTERRUPTION IN THERAPY NOTED. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT OUTCOME IS THE PT IS SATISFACTORY.

    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. KF1049976

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR INTRA-AORTIC BALLOON PUMP