BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX TRANSTAR PRESSURE TRANSDUCER

    MDR report key: 24506993 · Received March 4, 2026

    Report

    Report Number
    1526863-2026-00053
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DPT
    UDI-DI
    10351688503992
    PMA / PMN Number
    K942377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: CODES WERE UPDATED. NO DEVICE WAS RECEIVED FOR INVESTIGATION. THEREFORE, THE REPORTED COMPLAINT IS UNABLE TO BE CONFIRMED. IF THE DEVICE IS RECEIVED, THE INVESTIGATION WILL BE RE-OPENED FOR FURTHER EVALUATIONS. BASED ON THE REVIEW OF THE SERVICE HISTORY AND INFORMATION PROVIDED FROM THE CUSTOMER WE ARE UNABLE TO DETERMINE A PROBABLE CAUSE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO EVENT HISTORY LOG PROVIDED. COMPLAINT FOR THE FAILURE MODE ¿BLOOD LEAKAGE (LEAKING)¿ WAS CONFIRMED SINCE IN THE IMAGES PROVIDED BY CUSTOMER, WAS POSSIBLE TO IDENTIFY THE PRODUCT LEAKAGE AT THE SUBASSEMBLY P/N: 10023489-001, BETWEEN THE TUBING P/N: 125C-12 AND THE FEMALE LUER LOCK P/N: 550-007. CAPA: 0010338 HAS BEEN INITIATED TO INVESTIGATE LEAKAGE FAILURES ASSOCIATED WITH FINISHED GOOD MX9505T, WHICH HAS BEEN IDENTIFIED AS THE PRIMARY AFFECTED PRODUCT. THE LEAKAGE WAS LOCALIZED AT THE UNION BETWEEN TUBING P/N: 125-C AND THE FEMALE LUER LOCK P/N: 550-007.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIOLOGY DEPARTMENT CONNECTED IT FOR USE, THE DOCTOR NOTICED BLOOD LEAKAGE AT THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477500 MEDEX TRANSTAR PRESSURE TRANSDUCER PROBE, BLOOD-FLOW, EXTRAVASCULAR DPT ICU MEDICAL, INC. 6058630 10351688503992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown