BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1944024 · Received December 3, 2010

    Report

    Report Number
    1219856-2010-00885
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) CATHETER WAS PLACED IN THE OPERATING ROOM ON THE 16TH OF NOVEMBER. THE PATIENT (PT.) HAD AORTIC VALVE STENOSIS AND AN AORTIC VALVE REPAIR WAS DONE. ON THE 18TH OF NOVEMBER, THE UNIT MANAGER (UM) IN THE SURGICAL INTENSIVE CARE UNIT (SICU) PHONED THE SALES REPRESENTATIVE (SR) STATING THAT THE PUMP WAS ALARMING HELIUM LOSS ALARMS AND GIVING A READING OF MOISTURE IN THE SYSTEM. THE SR ASKED THE UM TO CHECK THE FOLLOWING: THE DRIVELINE TUBING FOR BLOOD IN THE TUBING (REMOVE THE CATHETER IF BLOOD WAS SEEN IN THE DRIVELINE TUBE). CHECK ALL THE CONNECTIONS AND MAKE SURE THAT THEY ARE TIGHTLY CONNECTED. CHECK THE ECG RHYTHM AND MAKE SURE THE TRIGGER IS SET APPROPRIATELY. CHECK THE WATER TRAP BEHIND THE HELIUM BOTTLE AND EMPTY THE BOTTLE; WHEN REPLACING THE BOTTLE, PULL THE TUBING FROM THE WATER TRAP A LITTLE TO ENSURE SOME TRACTION IN CASE THERE IS A KINK PRESENT. THE SR'S COLLEAGUE ASSISTED THE STAFF TO CHANGE THE TRIGGER AND TIMING ON THE PUMP AND THE ALARMS STOPPED. ON THE 19TH OF NOVEMBER THE STAFF FROM THE EP LAB WAS SETTING THE PT'S PACEMAKER WHEN THE UM NOTICED BLOOD WAS RAPIDLY FILLING THE DRIVELINE TUBING. AS A RESULT, THE UM CLAMPED THE TUBING AND CALLED THE MD. THE MD WAS IN THE UNIT AT THE TIME AND REMOVED THE IAB CATHETER. ACCORDING TO THE UM, THE BLOOD WOULD HAVE ENTERED THE PUMP IF SHE WAS NOT NEXT TO THE BED WHEN THE STAFF MADE CHANGES TO THE PT PACEMAKER SETTINGS. THE UM DID NOT RECALL ANY ALARMS GOING OFF ON THE PUMP. THE PT WAS FULLY SEDATED, VENTILATED AND HAD A PACEMAKER INSITU. THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS CONNECTED TO THE PT WITH THE ARTERIAL PORT IN THE RIGHT FEMORAL ARTERY AND THE VENOUS PORT CONNECTED TO THE LEFT FEMORAL VEIN. THE IAB CATHETER WAS PLACED IN THE LEFT FEMORAL ARTERY. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE IAB WAS REMOVED AND ANOTHER IAB WAS NOT REPLACED. THE MD DID NOT FEEL ANOTHER IAB WAS NECESSARY. IT WAS NOTED THAT THERE WAS NO DELAY OR INTERRUPTION IN IAB THERAPY. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT WAS DISCHARGED FROM THE INTENSIVE CARE UNIT TO THE WARD. THE PUMP USED WAS THE IAP-0050 SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INTRA-AORTIC BALLOON PUMP