BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AUTOCAT2 WAVE

    MDR report key: 18102681 · Received November 9, 2023

    Report

    Report Number
    3010532612-2023-00610
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    October 16, 2023
    Report Date
    October 16, 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).

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF "CATHLAB ALARM OF THE ISOLTEST" WAS NOT CONFIRMED UPON THE INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A MARTEK POWER SUPPLY (PART NUMBER: 77-0063-003, S/N: (B)(6)) FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A BROWN CARDBOARD BOX WITH PROTECTIVE SHIPPING PACKAGING (INP-1, INP-2). VISUAL INSPECTION OF THE POWER SUPPLY WAS PERFORMED (INP-3 THROUGH INP-11) 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 (ANP-1). 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 13.3 VOLTS (ANP-2). PUMPING WAS INITIATED (ANP-3). THE IABP GAVE A PROPER ALARM WHEN DISCONNECTED FROM THE AC POWER (ANP-4). THE IABP ALARMED PROPERLY WITH "LESS THAN 20 MINUTES REMAINING", "LESS THAN 10 MINUTES REMAINING", AND "LESS THAN 5 MINUTES REMAINING" ALARMS (ANP-5 THROUGH ANP-7). THE TOTAL BATTERY RUNTIME WAS OVER 90 MINUTES. THE PUMP PASSED THE BATTERY LOAD TEST. 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. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). IN SECTION B. 1, SELECTED PRODUCT MALFUNCTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, "THE IABP WAS TRIGGERING THE CATHLAB ALARM OF THE ISOLTEST WHEN CONNECTED TO THE POWER SOURCE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, "THE IABP WAS TRIGGERING THE CATHLAB ALARM OF THE ISOLTEST WHEN CONNECTED TO THE POWER SOURCE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, "THE IABP WAS TRIGGERING THE CATHLAB ALARM OF THE ISOLTEST WHEN CONNECTED TO THE POWER SOURCE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111729 ARROW AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown