BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE MONITOR

    MDR report key: 13962568 · Received March 31, 2022

    Report

    Report Number
    2015691-2022-04723
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    February 23, 2022
    Report Date
    May 6, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    QAQ
    PMA / PMN Number
    K203224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS FURTHER INFORMED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE THE HOSPITAL CONTINUES USING THE DEVICE. WITHOUT RETURN OF THE PRODUCT, EDWARDS IS UNABLE TO PERFORM A COMPLETE INVESTIGATION OF THE REPORTED EVENT. IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO IT, AND THEREFORE NO ACTIONS COULD BE PLANNED. AN ENGINEERING INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. 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 Manufacturer Narrative · 0

    AS PER FURTHER FOLLOW-UP IT WAS COMMUNICATED THAT THE PATIENT DID NOT PASS AWAY DURING THE PROCEDURE AND THE DEATH WAS NOT RELATED TO THE USE OF THE EDWARDS' DEVICE. ADDITIONALLY, IT WAS CONFIRMED THAT THERE IS NO ALLEGATION OF PRODUCT MALFUNCTION OR INCORRECT VALUES PROVIDED. HPI WORKED CORRECTLY AND AS EXPECTED. CUSTOMER WOULD ONLY LIKE TO CHECK THE HPI VALUE DURING THE PROCEDURE AS PART OF THEIR LEARNING PROCESS ABOUT HPI TECHNOLOGY. AS SUCH, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND A CORRECTED SUPPLEMENTAL REPORT IS BEING SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED, DURING USE IN AN ELECTIVE ABDOMINAL AORTIC ANEURYSM (AAA) OF THIS HEMOSPHERE MONITOR WITH ACUMEN HYPOTENSION PREDICTION INDEX (HPI), THE HPI VALUE WAS INACCURATE AND PATIENT PASSED AWAY. NO FURTHER INFORMATION WAS AVAILABLE. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872365 HEMOSPHERE MONITOR ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR QAQ EDWARDS LIFESCIENCES HEM1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death