BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP CONSOLE

    MDR report key: 25112881 · Received May 7, 2026

    Report

    Report Number
    MW5187864
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 4, 2026
    Manufacturer
    TELEFLEX LLC (NADC)
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    501
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD THE TELEFLEX IABP CATHETER PLACED ON (B)(6) 2026. ON (B)(6) 2026, A SIGNIFICANT MECHANICAL FAILURE WAS IDENTIFIED WHEN BLOOD WAS NOTED WITHIN THE IABP TUBING, WHICH STRONGLY SUGGESTS THE PRESENCE OF A MICROTEAR IN THE BALLOON MEMBRANE. OF PARTICULAR CONCERN IS THAT THERE WERE NO "HELIUM LOSS" ALARMS TRIGGERED ON THE CONSOLE ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525473 AC3 OPTIMUS IABP CONSOLE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP TELEFLEX LLC (NADC)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other