BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 3261854 · Received July 30, 2013

    Report

    Report Number
    1219856-2013-00185
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE HOTLINE FROM THE CHIEF OF PERFUSION (CP) TO THE FIELD SERVICE REPRESENTATIVE THAT THE CS NEEDED A CALL BACK AS SOON AS POSSIBLE. THE PUMP (AUTOCAT2WAVE S/N (B)(4)) WAS NOT ON THE PT AND THE CS DID NOT WANT TO WAIT ON THE PHONE. PER THE SALES REPRESENTATIVE DURING A PHONE CONVERSATION WITH THE CP; THE PT WAS ARRESTING IN THE OPERATING ROOM (OR). THE PT WAS NOT ON BYPASS YET AND DID NOT HAVE PACING WIRES IN YET SO IT IS BELIEVED THE CASE HAD JUST STARTED. PRIOR TO THE IAB-05840-LWS BEING INSERTED INTO PT, THE FIBEROPTIX SLIDER WAS HANDED OFF TO THE CP AND WHEN THE BALLOON WAS INSERTED, THERE WERE NO TONES AND NO LIGHT BULB CHANGE ON PUMP. THE CS ATTEMPTED SLIDING IN AND OUT A TOTAL OF THREE TIMES WITH SAME RESULTS. AS A RESULT, THE INTRA-AORTIC BALLOON (IAB) WAS NOT USED. A SECOND IAB WAS PREPPED AND THE FIBEROPTIX ZEROED THE FIRST TIME AND USED SUCCESSFULLY. THE PT ENDED UP EXPIRING INTRA-OPERATIVE. ADDITIONAL INFO RECEIVED ON (B)(4) 2013 PER THE SALES REPRESENTATIVE (SR) THE FEMALE PT EXPIRED. INDICATION FOR USE: ASSIST CARDIAC ARREST. THE PT WAS ADMITTED TO THE HOSPITAL DURING THE PREVIOUS WEEK. THE PT WAS STABLE AND WAITING OVER THE WEEKEND FOR SURGERY. SURGERY WAS ON MONDAY, (B)(6) 2013, WHILE ON THE OPERATING ROOM THE PT WENT INTO CARDIAC ARREST (THE SR WAS NOT TOLD WHY) AT THE BEGINNING OF THE CASE. THE PT WAS NOT ON BYPASS YET. THE DECISION WAS MADE TO INSERT AN IAB-05840-LWS FOR IABP (AUTOCAT2WAVE S/N (B)(4)) THERAPY. PRIOR TO THE INSERTION, THE PUMP DID NOT RECOGNIZE THE FIBEROPTIX; NO TONES, NO LIGHT BULB CHANGE. AS A RESULT, THE IAB WAS NOT USED. A NEW IAB KIT WAS OPENED AND INSERTED THROUGH THE SHEATH VIA FEMORAL WITHOUT DIFFICULTY OR PROBLEM. THERE WERE NO PUMP STRIPS GENERATED. PER THE CHIEF OF PERFUSION (COP), THERE WAS NO REPORT OF INJURY OR COMPLICATIONS. THE COP MADE THE MEDICAL JUDGEMENT THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THERE WAS A DELAY OR INTERRUPTION IN THERAPY OF JUST A SHORT TIME WHILE OPENING UP THE SECOND IAB, THERE IT WAS UNK IF IT CAUSED HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354918 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF2022436

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRA-AORTIC BALLOON PUMP