BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 3190703 · Received June 24, 2013

    Report

    Report Number
    1219856-2013-00153
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL ON (B)(6) 2013 AT 5:08 AM MDT THAT A 30 CC INTRA-AORTIC BALLOON (IAB) WAS INSERTED ON (B)(6) 2013 AT ABOUT 5 PM IN THE RIGHT FEMORAL IN A FEMALE PATIENT POST ANGIOGRAM TO KEEP PERFUSION THROUGH THE VESSELS WITH MULTIPLE LESIONS WHILE WAITING FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY ON MONDAY. THE CALL WAS FROM THE INTENSIVE CARE UNIT (ICU) RN REGARDING A POSSIBLE HELIUM LOSS ALARM AND BLOOD IN THE HELIUM TUBING. THE MD WAS NOTIFIED AND TOLD THE STAFF TO PLACE THE INTRA-AORTIC BALLOON PUMP (IABP) 1:4 AND KEEP PUMPING. SHE WAS NOT COMFORTABLE WITH THAT SINCE SHE KNEW THE BALLOON SHOULD COME OUT. THE CLINICAL SUPPORT SPECIALIST (CSS) EXPLAINED THAT IF BLOOD IS IN THE TUBING THERE IS A HOLE IN THE BALLOON AND THE RECOMMENDATION IS TO REMOVE THE IAB. WHEN THEY TRIED TO KEEP THE IABP RUNNING THEY KEPT GETTING ALARM AGAIN. THE CSS EXPLAINED THAT THEY SHOULD CALL THE PHYSICIAN BACK AND ADVISE HIM THAT THE IABP CONTINUES TO ALARM WHEN THEY TRY TO PUMP AND THAT THE RECOMMENDATION WAS TO STOP PUMPING, CLAMP THE TUBING AND PREPARE FOR IAB REMOVAL. THE RN STATED SHE WOULD DO THAT. THE PATIENT IS STABLE WITHOUT IABP SUPPORT. A RETURN CALL WAS MADE ONE HOUR AFTER THE IAB WAS REMOVED. ANOTHER IAB WAS NOT INSERTED AT THIS TIME AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285989 IAB: 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER SYSTEM (FOS) DSP ARROW INTL., INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON PUMP