BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 2171442 · Received June 30, 2011

    Report

    Report Number
    1219856-2011-00238
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 30, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE SALES REPRESENTATIVE DURING AN IN-SERVICE ON (B)(6) 2011 THAT A MALE PATIENT WAS MOVING AND UNCOOPERATIVE REQUIRING SEDATION (HALDOL). THE MD INSERTED THE SHEATHED INTRA-AORTIC BALLOON (IAB) VIA THE FEMORAL ARTERY WHEN THE PUMP (IAP-0500 S/N (B)(4)) ALARMED DURING THE CASE, AND PER THE MANAGER, THE TECHNICIAN "JUST RESET THE ALARM REPEATEDLY WITHOUT LOOKING UNDER THE DRAPES ON THE PATIENT." AT THE END OF THE CASE, THE DRAPE WAS REMOVED AND BLOOD WAS OBSERVED IN THE HELIUM DRIVELINE. AS A RESULT, THE IAB AND SHEATH WAS REMOVED AS ONE UNIT. ANOTHER SHEATH AND IAB WERE INSERTED VIA THE SAME INSERTION SITE SUCCESSFULLY. X-RAYS WERE PERFORMED. THERE WAS A DELAY/INTERRUPTION IN THERAPY FOR THE TIME IT TOOK TO PREPARE AND INSERT THE SECOND IAB. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. THE PATIENT'S OUTCOME IS GOOD. AS NOTED AN IN-SERVICE WAS PROVIDED TO THE CATH LAB STAFF ON (B)(4) 2011. A REVIEW OF IABP SETUP, FIBEROPTIX SENSOR (FOS) ZEROING AND EXTENSIVE DISCUSSION ON HELIUM ALARMS AND TROUBLESHOOTING OF ALARMS AS WELL AS ACTION REQUIRED FOR THOSE ALARMS. ALL STAFF IN ATTENDANCE VERBALIZED UNDERSTANDING.

    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