BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 19424133 · Received May 30, 2024

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    Report

    Report Number
    2015691-2024-04008
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 10, 2024
    Report Date
    August 9, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    PMA / PMN Number
    K223865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED AND THE EVALUATION COMPLETED. THE LOW TEMPERATURE VALUES THAT WERE REPORTED COULD NOT BE CONFIRMED. THERE WAS TESTING PERFORMED AND FUNCTIONAL TESTING DID FAIL DUE TO A DEFECTIVE MAIN BOARD. THE MAIN BOARD WILL BE REPLACED. THERE WAS NO PHYSICAL DAMAGE IDENTIFIED ON THE DEVICE. THE ENGINEERING EVALUATION WAS COMPLETED. THE REPORTED EVENT COULD NOT BE CONFIRMED OR REPLICATED DURING THE ANALYSIS. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. 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, DQE CATHETER, OXIMETER, FIBEROPTIC, 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. REFER TO REPORT ID FOR THE HEMOSPHERE MONITOR INVOLVED 2015691-2024-03993.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE INACCURATE CARDIAC OUTPUT, CARDIAC INDEX AND BLOOD TEMPERATURE READINGS THAT DISPLAYED ON THE HEMOSPHERE WITH USE WITH THE SWAN GANZ MODULE. THE CLINICIAN STATES THE VALUES SEEMED LOWER THAN EXPECTED. THE ACTUAL VALUES DISPLAYED AND WHAT WAS EXPECTED ARE NOT AVAILABLE. THERE IS NO CLINICAL EVIDENCE TO SHOW THE DIFFERENCE, ONLY THE CLINICIAN RELYING ON THEIR EXPERIENCE. TROUBLESHOOTING WAS NOT PERFORMED. IT IS UNKNOWN IF THERE WERE ANY ERROR/ALERT MESSAGES. IT IS UNKNOWN IF THE VALUES WERE INFLUENCED BY THE PATIENT'S CONDITION OR IF TREATMENT WAS PERFORMED BASED ON THE INACCURATE DISPLAYED VALUES. THE PATIENT'S DEMOGRAPHIC INFORMATION WAS REQUESTED BUT IS UNAVAILABLE. THERE WAS NO PATIENT HARM OR INJURY. A HEMOSPHERE INSTRUMENT WAS INVOLVED IN THIS CASE AND COULD NOT BE RULED OUT AS A POSSIBLE CONTRIBUTOR. A SEPARATE MDR WILL BE SUBMITTED FOR THE HEMOSPHERE INSTRUMENT. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS PENDING. ONCE EVALUATED AND COMPLETED THE PRODUCT EVALUATION FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149503 HEMOSPHERE HEMOSPHERE SWAN GANZ MODULE DQK EDWARDS LIFESCIENCES HEMSGM10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown