BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1172872 · Received September 19, 2008

    Report

    Report Number
    1219856-2008-00446
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    June 21, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS EVALUATED AND THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE, IT IS REPORTABLE. EVALUATION: IAB WAS RETURNED WITH SHEATH. GUIDEWIRES AND PUMP TUBING WERE NOT RETURNED. THERE WAS BLOOD ON EXTERIOR SURFACE OF BLADDER. FOS CONNECTOR WAS EXAMINED AND CENTER POST WAS RECESSED. CENTER POST WAS REPOSITIONED AND EVERY TIME A CONNECTION WAS ATTEMPTED, CENTER POST WOULD RECESS AGAIN (LIGHT LEVEL TEST COULD NOT BE PERFORMED). FOS FIBER WAS EXAMINED THROUGHOUT LENGTH OF BLADDER AND WAS INTACT. FOS CABLE WAS EXAMINED AND THERE WERE NO OBVIOUS KINKS. REFERENCE: FIBEROPTIX AP SENSOR ZEROING AND CALIBRATION GUIDE. NOTE: IF RESISTANCE IS MET DURING CONNECTION, DO NOT FORCE CONNECTION. PULL SLIDE CONNECTOR BACK SLIGHTLY AND REATTEMPT CONNECTION. WHEN FIBEROPTIX PRESSURE SIGNAL (FOS) IS NOT AVAILABLE, IAB IS STILL ABLE TO BE USED SINCE AN ARTERIAL PRESSURE (AP) SIGNAL IS AVAILABLE THROUGH CENTRAL LUMEN. A TRANSDUCER CAN BE CONNECTED TO CENTRAL LUMEN, AS IN ALL IABS, AND AP AND TIMING CAN BE MONITORING FROM THIS LOCATION. EFFECT OF NOT HAVING AN AP FOS SIGNAL IS ENHANCED WAVE INFLATION TIMING ALGORITHM IS NOT AVAILABLE IN AUTOPILOT MODE. A DEVICE HISTORY REVIEW (DHR) WAS CONDUCTED ON THE IAB AND IT MET ALL SPECIFICATIONS AND PASSED ALL IN-PROCESS TESTING. THERE WERE NO MANUFACTURING ABNORMALITIES ESTABLISHED BETWEEN THE DHR AND THE REPORTED COMPLAINT. FOS WAS RECESSED IN ITS HOUSING DUE TO EXCESSIVE FORCE APPLIED ON CONNECTION TO INTRA-AORTIC BALLOON PUMP (IABP). WHEN FOS IS NOT CORRECTLY CONNECTED TO IABP, THE LIGHT PATH CANNOT BE ESTABLISHED AND FOS WILL NOT BE RECOGNIZED BY IABP. MANAGEMENT WILL CONTINUE MONITORING COMPLAINT REPORTS FOR ANY TRENDS WHICH MAY APPEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN, THAT THE FIBEROPTIX SENSOR (FOS) ZEROED "THEN IT SWITCHED BACK TO NOT ZEROED." THE INTRA-AORTIC BALLOON (IAB) WOULD NOT ZERO AGAIN.

    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 INTERNATIONAL INC. MF8050913

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN