BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 19421938 · Received May 30, 2024

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    Report

    Report Number
    2015691-2024-03993
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 10, 2024
    Report Date
    August 7, 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 THE DEVICE TESTING WAS LEFT TO RUN FOR SEVERAL HOURS AND THERE WERE NO ERROR MESSAGES DISPLAYED. THE DEVICE PASSED ALL FUNCTIONAL TESTING. 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, AS THE DEVICE RESPONDED APPROPRIATELY DURING TESTING. 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. REFER TO CORRECTIONS TO D1 AND D2. 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 2015691-2024-03994 FOR THE SWAN GANZ MODULE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE INACCURATE CARDIAC OUTPUT, CARDIAC INDEX AND BLOOD PRESSURE READINGS THAT DISPLAYED ON THE HEMOSPHERE DURING USE, PER THE CLINICIAN. THEY STATED THE READINGS APPEARED TO BE LOWER THAN EXPECTED BASED ON THE CLINICIAN'S EXPERIENCE. THERE IS NO CLINICAL EVIDENCE THAT THE FACILITY CAN PROVIDE. THE READINGS THAT DISPLAYED ARE NOT AVAILABLE. TROUBLESHOOTING WAS NOT PERFORMED. IT IS UNKNOWN WHETHER THERE WERE ANY ERROR MESSAGES THAT OCCURRED. IT IS UNKNOWN IF THE VALUES WERE INFLUENCED BY THE PATIENT'S CONDITION OR IF ANY INAPPROPRIATE PATIENT TREATMENT WAS PERFORMED. THE PATIENT'S DEMOGRAPHIC INFORMATION WAS REQUESTED BUT IS UNAVAILABLE. THERE WAS NO PATIENT HARM OR INJURY. A SWAN GANZ MODULE WAS INVOLVED IN THIS CASE AND COULD NOT BE RULED OUT AS A POSSIBLE CONTRIBUTOR. A SEPARATE MDR WILL BE SUBMITTED FOR THE SWAN GANZ MODULE. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES. THE DEVICE HAS BEEN RECEIVED FOR PRODUCT EVALUATION; HOWEVER, THE FINDINGS ARE PENDING. ONCE THE EVALUATION FINDINGS ARE AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581419 HEMOSPHERE HEMOSPHERE ADVANCED MONITOR DQK EDWARDS LIFESCIENCES HEM1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown