BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 21480317 · Received February 27, 2025

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    Report

    Report Number
    2015691-2025-01373
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    February 13, 2025
    Report Date
    April 18, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQE
    PMA / PMN Number
    K163381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ARRIVED AND AN EVALUATION WAS PERFORMED. THE SUSPECT SWAN GANZ MODULE WAS CONNECTED TO A KNOWN WORKING HEMOSPHERE SYSTEM AND A CCO SIMULATOR FOR TESTING. MONITORING WAS LEFT TO RUN FOR OVER AN HOUR AND THE READINGS RECEIVED WERE IN THE EXPECTED RANGE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. 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 A MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED TO BE RETURNED, BUT HAS NOT YET ARRIVED FOR EVALUATION. ONCE IT HAS ARRIVED AND THE PRODUCT EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE FINDINGS. THE DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES. ADDITIONAL PRODUCT CODES, DQK, QAQ, MUD, DXN, DSB, QMS, FLL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE INACCURATE VALUES THAT DISPLAYED WITH A SWAN GANZ MODULE. THE DOCTOR STATED THE VALUES THAT DISPLAYED WERE NOT THE EXPECTED VALUES. THE VALUES THAT DISPLAYED AND THE VALUES THAT WERE EXPECTED WERE NOT PROVIDED. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER STATES THE SWAN GANZ MODULE IS SUSPECT. EXACT TROUBLESHOOTING STEPS THAT WERE PERFORMED ARE UNKNOWN. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030868 HEMOSPHERE HEMOSPHERE SWAN GANZ MODULE DQE EDWARDS LIFESCIENCES HEMSGM10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown