BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX MEDICAL AC3 OPTIMUS INTRA AORTIC BALLOON PUMP

    MDR report key: 24702538 · Received March 26, 2026

    Report

    Report Number
    MW5185980
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INTRA-AORTIC BALLOON PUMP MALFUNCTIONING - (B)(4), SERIAL # (B)(6) - ALARMING "NO ELECTROCARDIOGRAM SIGNAL" I CHANGED ALL THE LEADS, MOVED THE LEADS TO DIFFERENT AREAS TO SEE IF SIGNAL WOULD IMPROVE - CALLED THE IABP ON CALL REPRESENTATIVE WHO INSTRUCTED ME TO USE A CABLE THAT WAS LOCATED IN THE BLUE BAG ON THE SIDE OF IABP THAT WOULD CONNECT TO OUR MONITOR - I DID AS SHE INSTRUCTED - CONTINUED TO ALARM "NO ECG SIGNAL " SHE THEN INSTRUCTED ME TO GET ANOTHER ECG CORD . WE DID NOT HAVE ANOTHER ECG CORD AVAILABLE. WE ONLY HAVE 2 IABPS AND BOTH WERE IN USE. SHE THEN INSTRUCTED ME TO TURN OFF IABP (GIVEN PATIENT WAS STABLE ENOUGH TO WITHSTAND THIS) AND TURN BACK ON. I DID AS INSTRUCTED AND WHEN IT CAME BACK ON, ECG WAS WORKING AS IT SHOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756386 TELEFLEX MEDICAL AC3 OPTIMUS INTRA AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) AC3 OPTIMUS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention