BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF

    MDR report key: 22998248 · Received September 8, 2025

    Report

    Report Number
    1713468-2025-00013
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQE
    UDI-DI
    00840619060305
    PMA / PMN Number
    K091268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    RECEIVED: ONE (1) USED LIST# 52516-15, TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF; LOT# 14333507. ONE (1) USED LIST# 52516-15, TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF; LOT# 14333507 --> ONE (1) USED LIST# UNKNOWN, CLAVE; LOT# UNKNOWN VISUAL: THE REPORTED SAMPLES OF TWO (2) USED LIST# 52516-15, TRIOX¿ SVO2/CCO PA CATHETERS WERE RECEIVED. NO VISUAL ANOMALIES WERE OBSERVED. THE BALLOON WAS TESTED AND PERFORMED AS EXPECTED ON BOTH THE SAMPLES. THE THERMISTOR CABLE WAS ABLE TO BE CONNECTED TO THE REUSABLE CABLE. FUNCTIONAL: PER THE PRODUCT SPECIFICATION PSS.X.OPTICATH SECTION 8, THE THERMISTORS ARE ELECTRICALLY TESTED. THE CATHETER WAS CONNECTED TO A Q2 PLUS MONITOR (A-3G-181) AND THE CATHETER WAS PLACED IN A 37°C WATER BATH (T-1G-051). WHEN CONNECTED TO THE Q2 PLUS MONITOR (A-3G-181) BOTH THE CATHETERS WERE ABLE TO OBTAIN A CCO VALUE. THE PRODUCT HAD PERFORMED PER THE SPECIFICATIONS. THE REPORTED COMPLAINT OF NO CONTINUOUS CARDIAC OUTPUT (CCO) VALUE WAS NOT CONFIRMED ON THE RETURNED SET. NO VISUAL ANOMALIES WERE OBSERVED. THE BALLOON WAS TESTED AND PERFORMED AS EXPECTED ON BOTH SAMPLES. THE ELECTRICAL CHARACTERISTICS OF THE THERMISTOR WERE MEASURED AND FOUND TO BE WITHIN THE PRODUCT SPECIFICATIONS ON BOTH SAMPLES. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF WHERE IT WAS REPORTED THAT A TRIOX SVO2/CCO PA CATHETER IS UNABLE TO READ ACCURATE CARDIAC OUTPUT ON COGENT CCO MONITOR OR MANUAL THERMODILUTION WHICH COULD BE A THERMISTOR ISSUE. THE EVENT OCCURRED DURING CONTINUOUS CARDIAC OUTPUT MONITORING. THUS, THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND THERE WAS DELAY IN THERAPY REPORTED. THIS REPORT CAPTURES 2 OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056829 TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF CATHETER, OXIMETER, FIBER-OPTIC DQE ICU MEDICAL, INC. 14333507 00840619060305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown