BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX TUBES BLUSELECT SUCTIONAID

    MDR report key: 25150499 · Received May 12, 2026

    Report

    Report Number
    3012307300-2026-04863
    Event Type
    Death
    Date Received
    May 12, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ICU MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTC
    UDI-DI
    15019315104862
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    B2 AND B3 DATE OF DEATH AND DATE OF EVENT WAS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS STATED THAT THERE COULD HAVE BEEN AN ISSUE WITH THIS ITEM AS THE PATIENT¿S CONDITION GOT WORSE AND THEN PASSED AWAY. THERE WAS PATIENT INVOLVEMENT AND THE PATIENT DIED. CLINICAL EVALUATION WAS DONE. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED, AND THERE WAS INSUFFICIENT OBJECTIVE INFORMATION (PHOTOS/LOGS/HISTORY) TO DETERMINE PROBABLE CAUSE OR FAILURE MODE. MEDICAL CAUSALITY / RELATEDNESS ASSESSMENT PATIENT OUTCOME SEVERITY: DEATH. CAUSAL RELATIONSHIP TO DEVICE PERFORMANCE: INDETERMINATE BASED ON CURRENTLY AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526608 PORTEX TUBES BLUSELECT SUCTIONAID BAG, RESERVOIR BTC ICU MEDICAL CZECH REPUBLIC A. S 4189344 15019315104862

    Patients

    Seq Age Sex Outcome Treatment
    1