BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2211846 · Received July 20, 2011

    Report

    Report Number
    1219856-2011-00268
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ARROW INTERNATIONAL 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 EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL REPORT FROM THE RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) TO TROUBLESHOOT A HIGH PRESSURE ALARM. THE RN HAD SILENCED THE ALARM A "COUPLE OF TIMES." PER THE RN, THE PUMP "APPEARS TO BE AUGMENTING WELL." THERE IS BLOOD NOTED IN THE GAS LINE. THIS OCCURRED 8 - 10 HRS AFTER IABP THERAPY WAS STARTED. THE CSS VERIFIED THAT THE NOTED BLOOD IS INSIDE THE GAS LINE TUBING. THE RN REPORTS THAT THE BLOOD IS ACTUAL LIQUID. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED SHEATHLESS IN THE CATH LAB. THE PT RECENTLY RETURNED FROM THE OPERATING ROOM POST CORONARY ARTERY BYPASS GRAFT TO THE CARDIAC THORACIC UNIT. THE CSS EXPLAINED THAT THERE IS A LEAK IN THE MEMBRANE AND THE IAB MUST BE REMOVED. THE RN STATED HE "WAS AFRAID OF THAT BUT WANTED VERIFICATION." THE CSS TOLD THE RN THAT THE IAB SHOULD BE REMOVED AS SOON AS POSSIBLE; PUMPING SHOULD BE STOPPED AND THE IAB REMOVED WITHIN 30 MINS. THE CSS ALSO RECOMMENDED THAT THE RN DISCONNECT THE IAB FROM THE PUMP SO NO BLOOD GETS INTO THE PUMP AND TO KEEP THE IAB AFTER REMOVAL IN A RED BAG. THE CSS GAVE THE RN THE DIRECT NUMBER TO CALL BACK SHOULD THEY HAVE ANY ADD'L QUESTIONS. AS A RESULTS, THE RN CALLED THE MD REQUESTING TO HAVE THE IAB REMOVED. AT 0016 THE CSS CALLED THE RN BACK TO F/U. THEY HAD REMOVED THE IAB. THE PT WAS STABLE AT THIS TIME SO THEY HAVE NOT REINSERTED ANOTHER IAB. THE RN THANKED THE CSS FOR THE CALL. IT WAS NOTED THAT THE IAB WAS INSERTED SHEATHLESS VIA THE LEFT FEMORAL ARTERY. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO REPORT OF PT DEATH, INJURY OR COMPLICATIONS. THE PT OUTCOME IS PT IS STABLE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK