BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUROCAT2 WAVE

    MDR report key: 3921504 · Received June 9, 2014

    Report

    Report Number
    1219856-2014-00108
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY IN THERAPY NOTED. THE PATIENT OUTCOME IS THE PATIENT IS BEING SUPPORTED ON IABP THERAPY SUCCESSFULLY AS PLANNED. AN UPDATE RECEIVED ON (B)(6) 2014 FROM THE CLT CLARIFIED THAT ACCORDING TO THE STAFF THE 1ST PUMP GAVE THE PURGE PROBLEM SO THE SECOND PUMP WAS SET UP AND THEY HAD A PROBLEM SO THE SECOND PUMP WAS SET UP AND THEY HAD A PROBLEM WITH IT. THEY REATTACHED TO THE FIRST PUMP AND STILL THE PURGE SYSTEM PROBLEM EXISTED. THE CLT ARRIVED NO KNOWING THEY HAD REATTACHED TOT THE FIRST PUMP. THAT IS WHEN THE CSS ON CALL CALLED THE CLT AND THEY WENT OVER THE ONE THAT WAS ATTACHED, REMOVED IT, REATTACHED THE SECOND UNIT AND THEY WERE ABLE TO START PUMPING. THEY DID HAVE TO READJUST MEAN PRESSURE AND A FEW OTHER THINGS. AFTER LEARNING THEY HAD REATTACHED THE FIRST PUMP THAT CHANGED THE THOUGHT PATTERN. THE CLT USED THE CHANGED THE THOUGHT PATTERN. THE CLT USED THE SIMULATOR AND COULD NOT GET THAT PUMP TO WORK DUE TO PURGE PROBLEMS. THE FIELD SERVICE REPRESENTATIVE (FSR) WAS CONTACTED. THE FSR AND THE BIOMED PERFORMED TESTING AND THOUGHT THE VALVE ASSEMBLY WAS THE PROBLEM. THE PUMP WAS SENT TO BIOMED FOR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL FROM THE CATH LAB TECHNICIAN (CLT) TO THE CLINICAL SUPPORT SPECIALIST (CSS) ON (B)(6) 2014 AT 9:35 AM (B)(6) THAT THEY HAD A PATIENT IN THE CATH LAB AND HAD JUST INSERTED AN IAB-05840-LWS THROUGH THE SHEATH VIA RIGHT FEMORAL ARTERY WITHOUT ISSUE. THEY WERE GETTING "FOS SIGNAL WEKA" AND "PURGE FAILURE ALARMS" ON THE IAP-0500. THE FIBEROPTIC ICON WAS BLUE, THE FIBEROPTIC SENSOR (FOS) STATUS CODES WERE LL (LOW LIGHT), RE (RATIOMETRIC ERROR) AND THERE WAS A FIBEROPTIC WAVEFORM ON THE SCREEN. THE CSS VERIFIED THAT THE LIGHT WAS ON THE FIBEROPTIC AND NO THE TRANSDUCER. THE MEAN ARTERIAL PRESSURE (MAP) ON THE CENTRAL LUMEN WAS 85 AND THE MAP ON THE PUMP WAS 77. THE CSS AND CLT WENT THROUGH THE MAP CAL. THE ICON DID NOT TURN WHITE. THE CSS HAD THEM TRY TO START THE PUMP AND IT ALARMED "PURGE FAILURE." THE PUMP WAS IN OPERATOR MODE SO THE CSS HAD THEM PLACE IT BACK INTO AUTOPILOT MODE. THE CSS THEN VERIFIED THAT THERE WAS AN ECG, ARTERIAL PRESSURE (AP) AND GAS DRIVE TUBING CONNECTED TO THE PUMP. THE CLT STATED THAT THEY WERE CONNECTED. THE CSS NEXT HAD THE CLT CHECK TO MAKE SURE THAT THE HELIUM TANK WAS TURNED ON AND IT WAS. THE CSS ASKED IF THEY HAD A SECOND PUMP AVAILABLE AND THEY DID. THE CSS HAD THE CLT CONNECT THE ECG CABLE TO THE SECOND PUMP AND THEN THE GAS DRIVE TUBING. THE CSS THEN HAD THE CLT TRY PUMPING ON THE SECOND PUMP. THE CSS AND CLT CALIBRATED THE MAP; THE ICON WAS WHITE. THE FOS CODE WAS OKAY ON THE SECOND PUMP. THE CSS THEN HAD THE CLT TRY PUMPING ON THE SECOND PUMP. THE CSS AND CLT CALIBRATED THE MAP; THE ICON WAS WHITE. THE FOS CODE WAS OKAY ON THE SECOND PUMP. THE CSS THEN HAD THEM CONNECT THE CENTRAL LUMEN TO THE SECOND PUMP (SERIAL NUMBER (B)(4)). THE PATIENT WAS IN AN ATRIAL FIBRILLATION TO SINUS RHYTHM. THE CSS HAD THEM SEND THE FIRST PUMP TO THE BIOMED DEPARTMENT. THE CSS ALSO ASKED THEM TO PLACE A NOTE ON THE PATIENT'S CHART TO HAVE THE INTRA-AORTIC BALLOON (IAB) SAVED WHEN IT IS REMOVED. THERE WERE PUMP STRIPS GENERATED, BUT ARE NOT AVAILABLE FOR REVIEW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335005 AUROCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1