BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 16008519 · Received December 19, 2022

    Report

    Report Number
    3010532612-2022-00566
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    December 12, 2022
    Report Date
    December 12, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902172065
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). RETURNED FOR INVESTIGATION WAS A PCS ASSEMBLY (P/N: 96-3006-001, S/N: (B)(6)). THE SAMPLE WAS DROPPED OFF BY A FIELD SERVICE REPRESENTATIVE. VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED AND NO ABNORMALITY WAS NOTED. ALL VALVES WERE INDIVIDUALLY TESTED BY POWERING THEM ON AND OFF USING AN EXTERNAL POWER SUPPLY, AND ALL VALVES FUNCTIONED AS INTENDED. THE PCS ASSEMBLY WAS INSTALLED INTO A KNOWN GOOD LAB INVENTORY AC3 FOR FUNCTIONAL TESTING. THE SYSTEM WAS POWERED UP SUCCESSFULLY. WHEN PUMPING WAS INITIATED, THE 1 PSI RELIEF VALVE WAS ACTIVATED, THE SYSTEM THEN ALARMED PURGE FAILURE (5). PUMPING WAS REINITIATED WITH THE SAME RESULT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT OF "FLUID BACKUP INTO THE PUMP" IS CONFIRMED. THE 1PSI RELEASE VALVE COULD NOT HOLD THE PRESSURE AND CREATED A LEAK ALONG WITH A PURGE FAILURE 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 LEAK FROM 1PSI RELEASE VALVE. THE ROOT CAUSE OF LEAK IS UNDETERMINED. THE COMPLAINT IS CONSIDERED ISOLATED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    REPORTED AS "PURGE FAILURE ALARMS". IT WAS REPORTED THAT CALL CAME FROM BIOMED REGARDING A PUMP WITH PURGE FAILURE ALARMS WHILE SETTING UP THE PUMP PRIOR TO PATIENT USE. ULTIMATELY A DIFFERENT PUMP WAS USED ON THE PATIENT. THE REPORT STATES THAT "HE DID NOT HAVE ANY INFORMATION OTHER THAN THEY CONNECTED A SECOND CONSOLE AND EVERYTHING WORKED FINE. HE HAD ZERO INFORMATION REGARDING ANYTHING OTHER THAN REQUESTING SERVICE. PUMP SENT TO BIOMED". NO REPORT OF PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    REPORTED AS "PURGE FAILURE ALARMS". IT WAS REPORTED THAT CALL CAME FROM BIOMED REGARDING A PUMP WITH PURGE FAILURE ALARMS WHILE SETTING UP THE PUMP PRIOR TO PATIENT USE. ULTIMATELY A DIFFERENT PUMP WAS USED ON THE PATIENT. THE REPORT STATES THAT "HE DID NOT HAVE ANY INFORMATION OTHER THAN THEY CONNECTED A SECOND CONSOLE AND EVERYTHING WORKED FINE. HE HAD ZERO INFORMATION REGARDING ANYTHING OTHER THAN REQUESTING SERVICE. PUMP SENT TO BIOMED". NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2709580 AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN917285 N/A 10801902172065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown