BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 FAST FLOW FLUID WARMER

    MDR report key: 21767121 · Received April 3, 2025

    Report

    Report Number
    3012307300-2025-03736
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 1, 2025
    Report Date
    June 18, 2025
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    BSB
    PMA / PMN Number
    BK940056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D3: MFG ESTABLISHMENT NAME; ICU MEDICAL, INC. DEVICE EVALUATION: NO PRODUCT RETURNED FOR DEVICE ANALYSIS; A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE PROCEDURES OF A LEVEL 1, THE AIR PRESSURE SUPPLY DID NOT SEEM TO REACH 5.6 PSI +/- 2, AND THE PRESSURE CHAMBERS WERE NOT REACHING 280 MMHG. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736242 LEVEL 1 FAST FLOW FLUID WARMER WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB ICU MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown