BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AUTOCAT2 WAVE

    MDR report key: 18112669 · Received November 10, 2023

    Report

    Report Number
    3010532612-2023-00643
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 3, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    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

    QN# (B)(4). THE REPORTED COMPLAINT OF "HELIUM LOSS ALARM" WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A PCS A SSEMBLY (P/N 96-3006-001, S/N (B)(6) ). THE SAMPLE WAS RETURNED IN A BROWN CARDBOARD BOX WITH PROTECTIVE SHIPPING PACKAGING (INP-1 THROUGH INP-4). VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED (INP-5 THROUGH INP-12), AND DRIED BLOOD/CONDENSATION WAS NOTED INSIDE THE OUTLET PORT (INP-9), VENT PORT (INP-10), DRAIN PORT (INP-11) AND THE FACE SEAL PLATE/BELLOW PORT (INP-12). ALL VALVES WERE INDIVIDUALLY TESTED BY POWERING THEM ON AND OFF USING AN EXTERNAL POWER SUPPLY, AND THE VENT VALVE, DRAIN VALVE AND FILL VALVE WERE FOUND TO BE VERY STICKY. DRIED BLOOD WAS NOTED INSIDE THE MANIFOLD AND PNEUMATIC VALVES WHICH POTENTIALLY CREATED A BLOCKAGE INSIDE THE PNEUMATIC SYSTEM. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO BLOOD CONTAMINATION. 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 DRIED BLOOD BUILDUP INSIDE THE PCS ASSEMBLY. THE ROOT CAUSE OF HOW THE DRIED BLOOD ENTERED THE PCS ASSEMBLY IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHILE PERFORMING A DEMONSTRATION, THE PUMP START DISPLAYING HELIUM LOSS ALARM". NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHILE PERFORMING A DEMONSTRATION, THE PUMP START DISPLAYING HELIUM LOSS ALARM". NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHILE PERFORMING A DEMONSTRATION, THE PUMP START DISPLAYING HELIUM LOSS ALARM". NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805948 ARROW AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown