BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 16273033 · Received January 31, 2023

    Report

    Report Number
    3010532612-2023-00049
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 18, 2023
    Report Date
    January 18, 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

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

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. ADDITIONALLY NO RECORDER STRIP WAS RETURNED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    CONSISTENT HIGH BASELINE ALARM IMMEDIATELY UPON INSERTION AT THE BEDSIDE. INITIALLY HAD HIGH BASELINE ALARMS. THEY VERIFIED PLACEMENT AND REPOSITIONED THE PATIENT WITHOUT SUCCESS. THE ISSUE WAS RESOLVED BY EXCHANGING THE CONSOLE. NO PATIENT INJURY OR CONSEQUENCE. SEE ASSOCIATED MDR 3010532612-2023-00056.

    Description of Event or Problem · 0

    CONSISTENT HIGH BASELINE ALARM IMMEDIATELY UPON INSERTION AT THE BEDSIDE. INITIALLY HAD HIGH BASELINE ALARMS. THEY VERIFIED PLACEMENT AND REPOSITIONED THE PATIENT WITHOUT SUCCESS. THE ISSUE WAS RESOLVED BY EXCHANGING THE CONSOLE. NO PATIENT INJURY OR CONSEQUENCE. SEE ASSOCIATED MDR 3010532612-2023-00056.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052351 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 N/A.| N/A.