BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 21819628 · Received April 10, 2025

    Report

    Report Number
    2015691-2025-02801
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Report Date
    April 10, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER FOR THE INVOLVED DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. NO PRODUCT WAS RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. 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 FDA PRODUCT CODES ARE: DQE, QAQ, MUD, DXN, DSB, QMS, FLL.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A LITERATURE ARTICLE, "EVALUATION OF HYPOTENSION PREDICTION INDEX SOFTWARE IN PATIENTS UNDERGOING ORTHOTOPIC LIVER TRANSPLANTATION: RETROSPECTIVE OBSERVATIONAL STUDY," THAT, DURING USE, HPI ON THE HEMOSPHERE HAD FALSE POSITIVES WITHOUT SUBSEQUENT EPISODES OF HYPOTENSION. THERE WERE NO PATIENT INJURIES REPORTED. THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161946 HEMOSPHERE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES HEM1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown