BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 14208631 · Received April 26, 2022

    Report

    Report Number
    3010532612-2022-00134
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 28, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902084966
    PMA / PMN Number
    K162820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THIS COMPLAINT WAS RECEIVED VIA MEDWATCH (B)(4). THERE IS AN INVESTIGATION ONGOING INTO THIS REPORTED COMPLAINT. A SUPPLEMENT FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). NO IABP PART OR RECORDER STRIP WAS RETURNED TO TELEFLEX CHELMSFORD FOR INVESTIGATION. THE REPORTED COMPLAINT OF DOUBLE TRIGGERING IS NOT ABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. 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. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IABP TRIGGERED FROM EKG TO ARTERIAL PULSATION AND STARTED TO DOUBLE TRIGGER AND INFLATE ON SYSTOLE AND INFLATE DIASTOLE RESULTING IN CARDIAC ARREST REQUIRING TO RETURN ON CARDIAC BYPASS THEN VA ECMO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IABP TRIGGERED FROM EKG TO ARTERIAL PULSATION AND STARTED TO DOUBLE TRIGGER AND INFLATE ON SYSTOLE AND INFLATE DIASTOLE RESULTING IN CARDIAC ARREST REQUIRING TO RETURN ON CARDIAC BYPASS THEN VA ECMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026167 AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN001112 N/A 30801902084966

    Patients

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