BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE FORESIGHT MODULE

    MDR report key: 21001284 · Received December 23, 2024

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    2015691-2024-09949
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 5, 2024
    Report Date
    March 28, 2025
    Manufacturer
    EDWARDS LIFESCIENCE IRVINE
    Product Code
    MUD
    PMA / PMN Number
    K180003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DQK- COMPUTER, DIAGNOSTIC, PROGRAMMABLE. DQE- CATHETER, OXIMETER, FIBER-OPTIC. QAQ- ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. DXN- SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. DSB- PLETHYSMOGRAPH, IMPEDANCE. QMS- ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. FLL- THERMOMETER, ELECTRONIC, CLINICAL. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE RESULTS BECOME AVAILABLE. 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

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT WAS UNABLE TO BE CONFIRMED SINCE THE COMPLAINT AFFECTED UNIT WAS NOT RETURNED FOR EVALUATION, NEITHER AN IMAGE OR VIDEO OF CONFIRMED DEVICE DEFICIENCY WERE PROVIDED; THEREFORE, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED. THEREFORE, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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

    IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED. HOWEVER, ONE HEMOSPHERE FORESIGHT SENSOR MODULE WAS EVENTUALLY RETURNED FOR EVALUATION. IT WAS FOUND THAT THE STO2 READING FOR SENSOR 2 DROPS OUT WHEN THE SENSOR CABLE 2 IS MOVED. NO ISSUES OCCURRED WHEN A KNOWN WORKING SENSOR CABLE WAS INSTALLED FOR SENSOR 2. THE OUTER LAYER OF INSULATION WAS DAMAGED BUT THERE WAS NO VISIBLE DAMAGE TO THE INTERNAL WIRES. MOVING THE CABLE AT THE POINT OF DAMAGE DID NOT CAUSE A FAILURE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE REPORTED EVENT OF MISSING OR INACCURATE STO2 VALUES IS ASSOCIATED TO A MANUFACTURING DESIGN DEFECT. THIS FAILURE IS CONSISTENT WITH A STRESS ISSUE, BENDING OF THE CABLE CAUSES FAILURE, WHICH IS MOST LIKELY DUE TO UNINTENDED USE OF THE DEVICE. THERE WAS NO EVIDENCE OF PRODUCT NONCONFORMANCE OR LABELING/IFU INADEQUACIES IDENTIFIED. CURRENT RISK MITIGATIONS INCLUDE SYSTEM ALARMS, DISPLAYED MESSAGE ON HOST, AND MITIGATIONS ALSO INCLUDE IFU WARNINGS AND CAUTIONS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES. 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 THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ERROR MESSAGE. CHANNEL 2 WILL NOT READ OR READS LOW. SWAPPED CABLES TO RESOLVE ISSUE. NO PATIENT INJURY, EVENT OCCURRED BEFORE USE. EVENT WAS POST INDUCTION BUT PRIOR TO INCISION. THEY REPORTED THAT IT WAS NOT READING BUT WHEN A READING WOULD POP UP IT WOULD ONLY BE FOR A SECOND AND IN THE 40S. WHEN THE REP TESTED IT ON HERSELF SHE COULD NOT GET IT TO READ AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76768 HEMOSPHERE FORESIGHT MODULE OXIMETER, TISSUE SATURATION MUD EDWARDS LIFESCIENCE IRVINE HEMFSM10 21103878

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown