BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 16466944 · Received March 2, 2023

    Report

    Report Number
    3010532612-2023-00111
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 10, 2023
    Report Date
    February 10, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902172065
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). RETURNED FOR INVESTIGATION WAS AN AC3 FRONT END BOARD (FEB) (P/N: 33-1020-003, S/N: (B)(6)). THE SAMPLE WAS RETURNED IN THE FEB BOARD SHIPPING BOX WITHOUT 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 AC3 FOR FUNCTIONAL TESTING. THE PUMP WAS POWERED ON WITH NO ABNORMALITIES. A PATIENT SIMULATOR WAS CONNECTED TO THE PUMP AND PUMPING WAS INITIATED IN AUTOPILOT. PERFORMED ECG, AP SIGNAL AND TRIGGER CHECKLIST AND FAILED. THE FRONT END BOARD DID NOT RECOGNIZE THE ECG SKIN LEADS OR THE AP TRANSDUCER SIGNAL. THE PUMP PROPERLY ALARMED IN OPERATOR MODE WHEN THERE WAS NO SIGNAL IN THE SELECTED TRIGGER MODE. THE PUMP WAS LEFT TO RUN IN AUTOPILOT WITH THE MONITOR SIGNALS FOR OVER 30 MINUTES WITHOUT ANY FURTHER ALARMS OR ERRORS. 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 'NO ECG OR AP SIGNALS" IS CONFIRMED. DURING THE COMPLAINT INVESTIGATION, THE RETURNED FRONT END BOARD DID NOT DETECT ECG SKIN LEADS OR AP TRANSDUCER SIGNALS. 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 MISSING ECG AND AP SIGNALS. THE ROOT CAUSE OF THIS COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "NO ECG OR AP SIGNALS. REPLACED FE BOARD. BIOMED STATES THAT THE PUMP WAS SWITCHED OUT QUICKLY WITH NO PATIENT COMPLICATIONS." PATIENT STATUS IS REPORTED AS "UNCHANGED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "NO ECG OR AP SIGNALS. REPLACED FE BOARD. BIOMED STATES THAT THE PUMP WAS SWITCHED OUT QUICKLY WITH NO PATIENT COMPLICATIONS." PATIENT STATUS IS REPORTED AS "UNCHANGED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002541 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