BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1971514 · Received January 21, 2011

    Report

    Report Number
    1219856-2011-00029
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 19, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTROL NO. 27820. 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 BEING USED ON A MALE PATIENT IN THE INTENSIVE CARE UNIT IN CARDIOGENIC SHOCK. THE CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL AND A SHORT TIME AFTER INSERTION THE PATIENT BECAME UNCONSCIOUS. AT THE SAME TIME A LOT OF BLOOD FLOWED INTO THE HELIUM LINE. THE INTRA-AORTIC BALLOON PUMP (IABP) ALARMED HELIUM LOSS ALERT. IMMEDIATELY, THE PERFUSIONIST DISCONNECTED THE HELIUM LINE. THE IAB WAS REMOVED AND THE PATIENT WAS UNRESPONSIVE AND WAS HARDLY BREATHING. HE WAS IMMEDIATELY GIVEN ARTIFICIAL RESPIRATION. WHEN THE IAB WAS EXAMINED THEY NOTICED THAT THE BALLOON WAS DETACHED FROM THE CATHETER AT THE DISTAL END. ANOTHER IAB WAS INSERTED SUCCESSFULLY FOR THE PATIENT. IT IS UNKNOWN HOW LONG THE DELAY WAS IN TREATMENT TO THE PATIENT. THE PATIENT'S OUTCOME WAS OKAY.

    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 Required Intervention INTRA-AORTIC BALLOON PUMP