BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5896964 · Received August 23, 2016

    Report

    Report Number
    1219856-2016-00189
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 4, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PCS ASSEMBLY (P/N 96-3006-001W, S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED AND NOTED THE VENT PORT WAS RUSTED. NO OTHER ABNORMALITIES WERE NOTED. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED INTO KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE KNOWN GOOD AUTOCAT2W WITH THE PCS ASSEMBLY IN QUESTION INSTALLED FAILED THE FUNCTIONAL TEST. THE PUMP ALARMED "PURGE FAILURE" IMMEDIATELY AFTER PUMPING WAS INITIATED. THE PCS ASSEMBLY WAS THEN REMOVED FROM THE PUMP. THE PCS ASSEMBLY IN QUESTION WAS INSTALLED ONTO THE MDT-50 LEAK TESTER AND FAILED LEAK TESTING. A SMALL LEAK WAS DETECTED TO BE COMING FROM THE VENT PORT V1. THE VENT VALVE V1 WAS POWERED WITH 12 VDC USING EXTERNAL POWER SUPPLY AND NO CLICKING SOUND WAS NOTED. THE EXTERNAL POWER SUPPLY WAS THEN SWITCHED ON/OFF MULTIPLE TIMES AND STILL NO CLICKING SOUND WAS NOTED. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED AND FOUND THE RELEASE SPRING INSIDE THE VENT VALVE WAS STUCK. 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. CONCLUSION: THE REPORTED COMPLAINT OF "ALARM, PURGE FAILURE" IS CONFIRMED. THE REPORTED ALARM WAS REPLICATED DURING THE FUNCTIONAL TEST AT TELEFLEX (B)(4). THE PUMP ALARMED PURGE FAILURE IMMEDIATELY WHEN PUMPING WAS INITIATED. A LEAK WAS DETECTED TO BE COMING FROM THE VENT PORT AND WAS LIKELY CAUSED BY THE STUCK RELEASE SPRING IN THE VENT VALVE. THE PURGE FAILURE ALARM WAS CAUSED BY THE LEAK. THE CAUSE OF THE RELEASE SPRING MALFUNCTION IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: PREVENTATIVE MAINTENANCE (PM) & REPAIR CONSTANT PURGE FAILURES. FINDINGS / ACTION TAKEN: PERFORM PM AND FUNCTIONAL CHECK - WOULD NOT PUMP - PURGE FAILURES FOUND AND REPLACED DEFECTIVE PCS ASSY. REPLACED OLD BATTERY AND FOS CONNECTOR. FCN LEVEL: 1416. SOFTWARE LEVEL: 2.24. OP = ON PATIENT CONFIRMED. PUMP WAS SWAPPED OUT WITH NO PATIENT ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: PREVENTATIVE MAINTENANCE (PM) & REPAIR CONSTANT PURGE FAILURES. FINDINGS / ACTION TAKEN: PERFORM PM AND FUNCTIONAL CHECK - WOULD NOT PUMP - PURGE FAILURES FOUND AND REPLACED DEFECTIVE PCS ASSY. REPLACED OLD BATTERY AND FOS CONNECTOR. FCN LEVEL: 1416 SOFTWARE LEVEL: 2.24 OP = ON PATIENT CONFIRMED PUMP WAS SWAPPED OUT WITH NO PATIENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547526 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1