BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 3162504 · Received June 6, 2013

    Report

    Report Number
    1219856-2013-00125
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    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 "HEMODINAMICA" DEPARTMENT THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) VIA A SHEATH INTO THE PATIENT'S FEMORAL ARTERY. INDICATION FOR USE: AS A SUPPORT AFTER HEMODYNAMIC TREATMENT. THE IAB WAS PREPPED PER INSTRUCTION AND THE FIBEROPTIX SENSOR (FOS) WAS ZEROED PRIOR TO INSERTION. THE BLUE SENSOR AND CAL KEY WERE CONNECTED TO THE PUMP PRIOR TO THE INSERTION AND THE STAFF DID HEAR TWO CLICKS AS THE FOS CONNECTION WAS MADE TO THE INTRA-AORTIC BALLOON PUMP (IABP). AFTER INSERTING THE IAB, THE PUMP MESSAGE WAS "NO FOS WAVEFORM IS SEEN." AS A RESULT, THE MD REMOVED THE IAB AND SHEATH TOGETHER AS ONE UNIT SUCCESSFULLY. A SECOND ARROW IAB WAS INSERTED VIA THE SAME INSERTION SITE AND USED SUCCESSFULLY. THERE WAS NO PATIENT DEATH, INJURY OR COMPLICATIONS REPORTED. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED. THE IABP THERAPY WAS INTERRUPTED FOR 20 MINUTES. THE PATIENT OUTCOME IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251135 IAB: 8 FR - 40 CC FOS INTRA-AORIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF2114709

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON PUMP