BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AUTOCAT2 WAVE

    MDR report key: 18345795 · Received December 18, 2023

    Report

    Report Number
    3010532612-2023-00710
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 27, 2023
    Report Date
    November 29, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). RETURNED FOR INVESTIGATION WAS A MARTEK POWER SUPPLY (P/N: 77-0063-003, S/N: (B)(6)). VISUAL INSPECTION OF THE POWER SUPPLY WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE POWER SUPPLY WAS INSTALLED INTO A KNOWN GOOD AC2 FOR FUNCTIONAL TESTING. THE IABP POWERED UP SUCCESSFULLY WITH NO ALARM. THE POWER SUPPLY VOLTAGE CHECK WAS PERFORMED PER AC2 SERIES SERVICE MANUAL AND ALL OUTPUT VOLTAGES WERE PRESENT AND WITHIN SPECIFICATION. THE BATTERY LOAD TEST WAS PERFORMED. THE IABP WAS RUN ON BATTERY UNTIL THE IABP SHUT DOWN. THE BATTERIES WERE THEN LEFT TO CHARGE IN THE IABP FOR OVER 9 HOURS. THE FULL CHARGE OF BATTERIES WAS 13.0 VOLTS. PUMPING WAS INITIATED. THE IABP GAVE A PROPER ALARM WHEN DISCONNECTED FROM THE AC POWER. THE IABP ALARMED PROPERLY WITH "LESS THAN 20 MINUTES REMAINING", "LESS THAN 10 MINUTES REMAINING", AND "LESS THAN 5 MINUTES REMAINING" ALARMS. THE TOTAL BATTERY RUNTIME WAS OVER 90 MINUTES. THE PUMP PASSED THE BATTERY LOAD TEST. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT OF "PUMP POWERED OFF WHILE ON PATIENT" IS NOT CONFIRMED. THE RETURNED POWER SUPPLY 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. 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

    QN# (B)(4). IN SECTION D ADDED THE INFORMATION AVAILABLE FOR THE UDI #, THERE WAS NO LOT NUMBER REPORTED. THEREFORE, THE FULL UDI # IS UNABLE TO BE PROVIDED. UDI RELATED DATA QUALITY UPDATES ONLY. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    QN#(B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "PUMP POWERED OFF WHILE ON PATIENT. PM AND REPLACE BATTERY". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "PUMP POWERED OFF WHILE ON PATIENT. PM AND REPLACE BATTERY". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "PUMP POWERED OFF WHILE ON PATIENT. PM AND REPLACE BATTERY". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60367 ARROW AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC N/A

    Patients

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