BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 16305340 · Received February 6, 2023

    Report

    Report Number
    3010532612-2023-00077
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    February 2, 2023
    Report Date
    February 2, 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

    QN# (B)(4). RETURNED FOR INVESTIGATION WAS AN AUTOCAT2 FRONT END BOARD (FEB) (P/N: 77-1010-001, S/N: (B)(6). THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS FURTHER ENCLOSED IN AN FEB BOARD SHIPPING BOX WITH AN ELECTROSTATIC PROTECTIVE BAG. VISUAL INSPECTION OF THE FRONT END BOARD WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE FRONT-END BOARD WAS INSTALLED INTO A KNOWN GOOD AC2 FOR FUNCTIONAL TESTING. THE PUMP WAS POWERED ON WITH NO ABNORMALITIES. A PATIENT SIMULATOR WAS CONNECTED TO THE PUMP AND PUMPING WAS INITIATED. THE HELIUM TANK PRESSURE WAS READ CORRECTLY. THE FRONT END BOARD PASSED VOLTAGE CHECK, BP TRANSDUCER, AND STATIC RAM MEMORY. PERFORMED ECG, AP SIGNAL AND TRIGGER CHECKLIST AND PASSED. THE PUMP WAS LEFT TO RUN FOR APPROXIMATELY 1 HOUR AND NO ALARMS OR ERRORS WERE 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. THE RETURNED DEVICE PASSED VISUAL AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT OF "MACHINE DID NOT READ THE VALUE OF HELIUM PSI OF THE CANISTER" IS NOT CONFIRMED. THE RETURNED FRONT-END BOARD PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. 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, "CORRECTIVE MAINTENANCE REQUIRED BECAUSE THE MACHINE DID NOT READ THE VALUE OF HELIUM PSI OF THE CANISTER. THERAPY HAS BEEN COMPLETED, NO ADVERSE PATIENT CONDITION REPORTED." ADDITIONAL INFORMATION STATES THAT THE ISSUE WAS RESOLVED BY SWAPPING OUT THE PUMP. NO MEDICAL INTERVENTION NECESSARY. NO ADVERSE PATIENT CONDITION REPORTED BY THE PATIENT. THE FRONT END BOARD HAS BEEN REPLACED. THE MACHINE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, "CORRECTIVE MAINTENANCE REQUIRED BECAUSE THE MACHINE DID NOT READ THE VALUE OF HELIUM PSI OF THE CANISTER. THERAPY HAS BEEN COMPLETED, NO ADVERSE PATIENT CONDITION REPORTED." ADDITIONAL INFORMATION STATES THAT THE ISSUE WAS RESOLVED BY SWAPPING OUT THE PUMP. NO MEDICAL INTERVENTION NECESSARY. NO ADVERSE PATIENT CONDITION REPORTED BY THE PATIENT. THE FRONT END BOARD HAS BEEN REPLACED. THE MACHINE WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99932 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000320 N/A 30801902051715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| N/A.