BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 16108250 · Received January 5, 2023

    Report

    Report Number
    3010532612-2023-00012
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 3, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902051715
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETURNED FOR INVESTIGATION WAS AN AUTOCAT2 PCS ASSEMBLY (P/N: 96-3006-001, S/N: (B)(6)). VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PER FORMED AND NO ABNORMALITY WAS NOTED. THE RETURNED PCS ASSEMBLY WAS INSTALLED INTO A KNOWN GOOD AUTOCAT2W FOR FUNCTIONAL TESTING. THE SYSTEM WAS POWERED UP SUCCESSFULLY. THE PUMP ALARMED FOR PURGE FAILURE (5) WHEN PUMPING WAS INITIATED. THE PCS ASSEMBLY WAS THEN RE MOVED FROM THE PUMP. ALL VALVES WERE INDIVIDUALLY TESTED BY POWERING THEM ON AND OFF USING AN EXTERNAL POWER SUPPLY, AND THE VENT VALVE V1 DID NOT RESPOND WHEN THE POWER 12 VDC WAS APPLIED. VISUAL INSPECTION OF THE PCS ASSEMBLY INTERNAL HARDWARE WAS PERFORMED. THE RELEASE SPRING IN THE VENT VALVE WAS STUCK. NO OTHER ABNORMALITY WAS NOTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE SERIAL NUMBER/LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE RISK IS ACCEPTABLE. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS. THE REPORTED COMPLAINT OF "PURGE FAILURE ALARM" IS CONFIRMED. THE RELEASE SPRING INSIDE THE VENT VALVE WAS FOUND STUCK WHICH CAN CAUSE THE ALARM. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE RECEIVED PRODUCT DID NOT MEET SPECIFICATIONS DURING THE COMPLAINT INVESTIGATION DUE TO THE RELEASE SPRING BEING STUCK INSIDE THE VENT VALVE. THE ROOT CAUSE OF HOW TO RELEASE SPRING BECAME STUCK IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS. OTHER REMARKS: N/A, CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP DISPLAYED A "PURGE FAILURE" ALARM WHEN INITIATING THERAPY ON A PATIENT. THE PUMP WAS SWAPPED OUT FOR ANOTHER PUMP AND THERAPY WAS CONTINUED WITH NO ISSUES. NO REPORTED PATIENT HARM OR INJURY. THE PSC WAS REPLACED AND THE PUMP WAS PLACED BACK IN SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP DISPLAYED A "PURGE FAILURE" ALARM WHEN INITIATING THERAPY ON A PATIENT. THE PUMP WAS SWAPPED OUT FOR ANOTHER PUMP AND THERAPY WAS CONTINUED WITH NO ISSUES. NO REPORTED PATIENT HARM OR INJURY. THE PSC WAS REPLACED AND THE PUMP WAS PLACED BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345520 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000320 N/A 30801902051715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown