BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 3162490 · Received June 6, 2013

    Report

    Report Number
    1219856-2013-00123
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 7, 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
    IT
    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 THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE PATIENT'S "LEG" USING A SHEATH. THIRTY FIVE MINUTES LATER WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) THE PUMP ALARMED "HELIUM LOSS" AND BLOOD WAS NOTED IN THE HELIUM LINE. AT THIS TIME THE IAB WAS REMOVED. ANOTHER IAB WAS NOT INSERTED. THERE WAS NO REPORTED PATIENT DEATH INJURY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WAS INTERRUPTED HOWEVER, THE INTERRUPTION DID NOT HARM THE PATIENT. THE PATIENT OUTCOME IS LISTED AS GOOD. NO MEDICAL / SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 STATED THE INSERTION SITE WAS THE RIGHT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251513 IAB: 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF2124804

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INTRA-AORTIC BALLOON PUMP