BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 23855967 · Received December 19, 2025

    Report

    Report Number
    2015691-2025-10380
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 9, 2025
    Report Date
    February 12, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQE
    UDI-DI
    00690103197006
    PMA / PMN Number
    PREMARK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR PRODUCT EVALUATION. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS NO DEVICE WAS RETURNED, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING WARNINGS: POSSIBLE CAUSES OF INACCURATE VALUES MAY BE INCORRECT PLACEMENT OR POSITION OF THE CATHETER, EXCESSIVE VARIATIONS IN PULMONARY ARTERY BLOOD TEMPERATURE. ADDITIONALLY, CLOT FORMATION ON THE THERMISTOR, ANATOMICAL ABNORMALITIES (FOR EXAMPLE, CARDIAC SHUNTS), EXCESSIVE PATIENT MOVEMENT, ELECTROCAUTERY OR ELECTROSURGICAL UNIT INTERFERENCE, AND RAPID CHANGES IN CARDIAC OUTPUT.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT NOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. ADDITIONAL PRODUCT CODES: DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE. QAQ: ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. MUD: OXIMETER, TISSUE SATURATION. DXN: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. DSB: PLETHYSMOGRAPH, IMPEDANCE. QMS: ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. FLL: THERMOMETER, ELECTRONIC, CLINICAL. OLW: INDEX GENERATING ELECTROENCEPHALOGRAPH SOFTWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THIS HEMOSPHERE MONITOR, IT WAS SUSPECTED OF PROVIDING INCORRECT SVR. THE CABLE WAS TRIED ON ANOTHER MONITOR AND WORKED. SWITCHING OUT THE MONITOR FOR ANOTHER MONITOR CORRECTED THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134941 HEMOSPHERE CATHETER, OXIMETER, FIBEROPTIC DQE EDWARDS LIFESCIENCES HEM1 00690103197006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown