BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 5953267 · Received September 15, 2016

    Report

    Report Number
    1219856-2016-00199
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 22, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 KNOWN GOOD AUTOCAT2W AND PERFORMED FUNCTIONAL TESTING. THE PUMP ALARMED "UNABLE TO REFILL" APPROXIMATELY 20 MINUTES AFTER PUMPING WAS INITIATED. THE KNOWN GOOD AUTOCAT2W 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 PASSED LEAK TESTING. ALL VALVES WERE POWERED WITH 12 VDC USING EXTERNAL POWER SUPPLY AND CLICKING SOUND WAS NOTED; HOWEVER, THE FILL VALVE (V2) WAS NOTED TO BE DELAY ON TRIGGER (CLICKING SOUND) APPROXIMATELY ONE SECOND WHEN POWER WAS APPLIED. THE EXTERNAL POWER SUPPLY WAS THEN SWITCHED ON/OFF MULTIPLE TIMES AND ONE SECOND DELAY STILL OCCURRED. SEE OTHER REMARKS SECTION. OTHER REMARKS: THE SUSPECTED FILL VALVE (V2) WAS REMOVED AND REPLACED WITH A KNOWN GOOD FILL VALVE (V2). THE PCS ASSEMBLY WAS THEN REINSTALLED INTO A KNOWN GOOD AUTOCAT2W AND THE FUNCTIONAL TEST WAS PERFORMED. THE PUMP WAS RAN FOR OVER 8 HOURS AND NO ALARMS OR ERRORS WERE OCCURRED. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED AND DRIED CONDENSATIONS WERE NOTED ON AND INSIDE THE MANIFOLD (WHERE DRAIN VALVE AND FILL VALVE CONNECTED). NOTICE: THIS IS AN ORIGINAL PCS ASSEMBLY FOR THIS 2009 PUMP. 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, UNABLE TO REFILL" IS CONFIRMED. THE PUMP ALARMED "UNABLE TO REFILL" APPROXIMATELY TWENTY MINUTES AFTER PUMPING WAS INITIATED. THE FILL VALVE (V2) WAS NOTED TO BE STICKY, WHICH POTENTIALLY CAUSED THE ALARM. THE CAUSE OF THE STICKY VALVE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: (B)(4) SYMPTOM: PUMP HAD "UNABLE TO REFILL" ALARMS WHILE ON PATIENT. THE PUMP WAS SWITCHED OUT QUICKLY WITH NO PATIENT COMPLICATIONS. FINDINGS/ACTION TAKEN: PCS ASSEMBLY SENT TO AND REPLACED BY HOSPITAL BIOMED. PART BEING RETURNED ON (B)(4) FCN LEVEL: (B)(4), SOFTWARE LEVEL: 2.24 OP = ON PATIENT AND CONFIRMED BY BIOMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FIELD SERVICE REPORT: L611357. SYMPTOM: PUMP HAD "UNABLE TO REFILL" ALARMS WHILE ON PATIENT. THE PUMP WAS SWITCHED OUT QUICKLY WITH NO PATIENT COMPLICATIONS. FINDINGS/ACTION TAKEN: PCS ASSEMBLY SENT TO AND REPLACED BY HOSPITAL BIOMED. PART BEING RETURNED ON WWS-AR#01722. FCN LEVEL: 1416, SOFTWARE LEVEL: 2.24. OP = ON PATIENT AND CONFIRMED BY BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605146 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1