BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 DR - 40 CC FOS

    MDR report key: 4120902 · Received July 28, 2014

    Report

    Report Number
    1219856-2014-00133
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RN IN THE CARDIAC CATH LAB (CCL) CALLED REGARDING A MALE PATIENT, (B)(6), NORMAL SINUS RHYTHM (NSR) WITH RATE 67/MIN NO PRESSURE AND NO TORTUOSITY OF AORTA NOTED. A 40 CC FIBEROPTIX SENSOR (FOS) INTRA-AORTIC BALLOON (IAB) WAS INSERTED AND THEY WERE GETTING HELIUM LOSS ALARMS EVERY 1-2 MINUTES SINCE PUMPING WAS INITIATED. THE RN VERIFIED THAT THERE WAS NO BLOOD VISIBLE IN THE HELIUM DRIVELINE TUBING AT THIS TIME. HE STARTED THE PUMP AGAIN AND WITHIN 30 SECONDS THE HELIUM LOSS ALARM OCCURRED AGAIN. THE CLINICAL SUPPORT SPECIALIST (CSS) EXPLAINED THE ALARM REFLECTS THAT THE 40 CC VOLUME WAS NOT RETURNING TO THE INTRA-AORTIC BALLOON PUMP (IABP) BEFORE THE NEXT SYSTOLE BEGAN AND COULD ALSO BE RELATED TO A KINKING OF THE IAB. THE CSS AND RN DISCUSSED THE POSSIBILITY OF DECREASING THE IAB VOLUME. AT THIS TIME, THE RN STATED THAT A NURSE FROM THE CARDIAC INTENSIVE CARE UNIT (CICU) HAD COME TO ASSIST WITH THE TROUBLESHOOTING AND THE MD WANTED TO CHANGE THE IABP CONSOLE. THE CSS EXPLAINED THIS MOST LIKELY WOULD NOT HAVE AN EFFECT ON THE ALARM. THE CSS REQUESTED THE RN TO CALL THE CSS BACK WHEN THE CAN. AT 9:55 PM EDT THE CSS RECEIVED A CALL FROM THE RN IN THE CICU WHO STATED THAT THEY HAVE CHANGED THE IABP CONSOLE WITH NO CHANGE IN ALARM STATUS. FLUOROSCOPY HAS VERIFIED IAB POSITION AND INFLATION. THE RN HAS CURRENTLY DECREASED THE IAB VOLUME TO 30 CC AND HELIUM LOSS ALARMS CONTINUE TO OCCUR. THE CSS SAID THE IAB VOLUME COULD BE SAFELY DECREASED TO 28 CC (2/3 TOTAL VOLUME) BUT WILL ALSO DECREASE THE OUTCOMES RECEIVED BY THE PATIENT. THE CSS INSTRUCTED THE RN THROUGH A HELIUM LEAK TEST, WITH NO CHANGE IN BALLOON PRESSURE WAVEFORM (BPW) BASELINE EVENT WHEN THE DRIVELINE WAS KINKED AS CLOSE TO THE PATIENT AS POSSIBLE. THE CSS EXPLAINED HOW THIS REFLECTS THAT THE HELIUM LOSS/KINK IS INTERNAL AND THE RECOMMENDATION WOULD BE TO REPLACE THE IAB. THE RN SAID THE PATIENT CARDIAC INDEX IS 1.27 AND THEY FEEL THAT THIS MAY BE RELATED TO THE ALARM. THE CSS EXPLAINED THE MEANING OF THIS ALARM TO THE RN AND THAT IT DID NOT REFLECT THE PATIENT HEMODYNAMICS< (>,<) > BUT THE TRANSITION OF THE HELIUM IN AND OUT OF THE IAB. RN STATED THAT HE WILL DISCUSS WITH THE MD. THE CSS REQUESTED THAT THE RN CALL BACK WITH AN UPDATE. AT 11:30 PM EDT THE CSS RETURNED A CALL TO THE RN FOR AN UPDATE. ACCORDING TO THE RN THEY ARE CURRENTLY TRANSPORTING THE PATIENT TO UNIT AND HE WILL CALL THE CSS BACK. AT 11:45 PM EDT THE RN RETURNED THE CALL AND SAID THE IAB WAS REMOVED AND A SECOND 40 CC IAB WAS INSERTED IN THE SAME SIDE WITHOUT DIFFICULTY. THE RN SAID PUMPING WAS STARTED IMMEDIATELY AFTER INSERTION AND THERE HAVE BEEN NO FURTHER ALARMS. THE PATIENT WAS TRANSFERRED TO THE UNIT IN STABLE CONDITION. THE RN ALSO SAID THE IAB THAT WAS REMOVED HAS BEEN SAVED FOR RETURN AND WILL BE SENT TO THE DEPARTMENT HANDLING RETURNS ON MONDAY ((B)(4) 2014). THE RN HAS NO FURTHER QUESTIONS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439794 IAB: 8 DR - 40 CC FOS INTRA-AROTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. 18F14A006

    Patients

    Seq Age Sex Outcome Treatment
    1