BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROAUTOCAT 2 WAVE

    MDR report key: 5660541 · Received May 17, 2016

    Report

    Report Number
    1219856-2016-00117
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    April 27, 2016
    Report Date
    April 27, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE PCS ASSEMBLY (P/N 96-3006-001, S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED AND NO ABNORMALITIES WERE NOTED. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE PURGE CYCLE WAS PERFORMED MULTIPLE TIMES AND PASSED EACH TIME WITHOUT ALARM; HOWEVER, THE PCS ASSEMBLY FAILED HELIUM LEAK TEST (PATIENT SIDE), THE BALLOON BASELINE PRESSURE DROPPED 6 MMHG APPROXIMATELY 15 MINUTES AFTER THE PUMP WAS INITIATED PUMPING. THE KNOWN GOOD AUTOCAT2W (ENG081202W)WITH THE PCS ASSEMBLY IN QUESTION INSTALLED FAILED THE FUNCTIONAL TEST. THE PCS ASSEMBLY WAS THEN REMOVED FROM THE PUMP. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED ONTO THE LEAK TESTER AND FAILED LEAK TESTING. A SMALL LEAK WAS NOTED TO BE COMING FROM THE DRAIN PORT. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED. RUST AND DRIED CONDENSATIONS WERE FOUND INSIDE THE DRAIN VALVE AND MANIFOLD BLOCK WHERE THE DRAIN VALVE WAS CONNECTED. NOTICE: THE PURGE FAILURE ALARM WOULD OCCUR IF SYSTEM COULD NOT PULL A NEGATIVE PRESSURE (DRAIN VALVE). OTHER REMARKS: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - PURGE FAILURE (5). FINDINGS/ACTION TAKEN: CONFIRMED FAILURE. COULD NOT PULL NEGATIVE (DRAIN VALVE). REPLACED PCS (PNEUMATIC CONTROL SWITCH); ALL WORKS, BUT HAS A SMALL HELIUM LOSS TRACED TO INTERFACE BLOCK. REPLACED INTERFACE BLOCK. FUNCTIONAL CHECK WAS PERFORMED; PASS ALL. SOFTWARE LEVEL: 2.24. ADDITIONAL INFORMATION STATED THAT THE TRANSPORT TEAM ARRIVED AND THE PATIENT WAS ON A COMPETITOR'S INTRA-AORTIC BALLOON PUMP (IABP). WHEN THE TEAM SWAPPED OUT THE PUMP THE ARROW PUMP ALARMED PURGE FAILURE (5). AS A RESULT, THE PATIENT WAS PUT BACK ON THE COMPETITOR'S PUMP AND A SECOND TRANSPORT TEAM WAS CALLED. THE SECOND TEAMS ARROW PUMP WORKED FINE AND THE PATIENT WAS TRANSPORTED TO THE NEXT FACILITY. THERE WAS A REPORTED DELAY IN TRANSPORT, NOT IN IABP THERAPY. IT IS UNKNOWN IF THE DELAY / INTERRUPTION WAS DETRIMENTAL TO THE PATIENT'S HEALTH PLAN.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: SYMPTOM - PURGE FAILURE (5). FINDINGS/ACTION TAKEN: CONFIRMED FAILURE. COULD NOT PULL NEGATIVE (DRAIN VALVE). REPLACED PCS (PNEUMATIC CONTROL SWITCH); ALL WORKS , BUT HAS A SMALL HELIUM LOSS TRACED TO INTERFACE BLOCK. REPLACED INTERFACE BLOCK. FUNCTIONAL CHECK WAS PERFORMED; PASS ALL. SOFTWARE LEVEL: 2.24. ADDITIONAL INFORMATION STATED THAT THE TRANSPORT TEAM ARRIVED AND THE PATIENT WAS ON A COMPETITOR'S INTRA-AORTIC BALLOON PUMP (IABP). WHEN THE TEAM SWAPPED OUT THE PUMP THE ARROW PUMP ALARMED PURGE FAILURE (5). AS A RESULT, THE PATIENT WAS PUT BACK ON THE COMPETITOR'S PUMP AND A SECOND TRANSPORT TEAM WAS CALLED. THE SECOND TEAMS ARROW PUMP WORKED FINE AND THE PATIENT WAS TRANSPORTED TO THE NEXT FACILITY. THERE WAS A REPORTED DELAY IN TRANSPORT, NOT IN IABP THERAPY. IT IS UNKNOWN IF THE DELAY / INTERRUPTION WAS DETRIMENTAL TO THE PATIENT'S HEALTH PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316182 AEROAUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC. 40540W

    Patients

    Seq Age Sex Outcome Treatment
    1