BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLUIDSMART FLUID MANAGEMENT SYSTEM

    MDR report key: 14877463 · Received June 30, 2022

    Report

    Report Number
    3007495879-2022-00001
    Event Type
    Death
    Date Received
    June 30, 2022
    Date of Event
    May 15, 2022
    Report Date
    September 14, 2022
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIG
    UDI-DI
    00860936000310
    PMA / PMN Number
    K091939
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO THE FACILITY TO OBTAIN FURTHER INFORMATION REGARDING THE PATIENT'S CONDITION; HOWEVER, THE USER FACILITY DID NOT RESPOND. UPON CONSULTATION WITH THE STRYKER CLINICAL TEAM, CONSISTING OF: A SENIOR GLOBAL MEDICAL DIRECTOR, A SENIOR MEDICAL SAFETY MANAGER, AND A CLINICAL OPERATIONS DIRECTOR IT WAS DETERMINED THAT THE DEVICE DID NOT LIKELY CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH FOR THE FOLLOWING REASONS: THE PATIENT WAS UNDERGOING A HYSTEROSCOPY PROCEDURE, WHICH HAS A POTENTIAL FOR RESPIRATORY DISTRESS AND DEATH BY AIR EMBOLISM. THE THERMEDX DEVICE USES SALINE, WHICH IS UNLIKELY TO CAUSE AN ANAPHYLAXIS REACTION. THE THERMEDX DEVICE DOES NOT USE CO2 GAS, WHICH ELIMINATES THE RISK FOR AN AIR EMBOLISM. BASED ON THE INFORMATION PROVIDED BY THE STRYKER CLINICAL TEAM IT WAS DETERMINED THAT THE DEATH WAS LIKELY CAUSED BY ANAPHYLAXIS CAUSED BY ANESTHESIA OR ANOTHER MEDICATION USED DURING SURGERY, OR CAUSED BY A VENOUS GAS EMBOLISM DUE TO THE RISKS ASSOCIATED WITH THE HYSTEROSCOPY PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE FLUID MANAGEMENT SYSTEM BAGS WERE SHOWING AS EMPTY. WHILE TRYING TO RECALIBRATE THE MACHINE THE PATIENT BECAME DISTRESSED AND A STAFF MEMBER ACCIDENTALLY UNPLUGGED THE MACHINE. THE ANESTHESIOLOGIST HAD TROUBLE ESTABLISHING AN AIRWAY AND THE PATIENT PASSED AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE FLUID MANAGEMENT SYSTEM BAGS WERE SHOWING AS EMPTY. WHILE TRYING TO RECALIBRATE THE MACHINE THE PATIENT BECAME DISTRESSED AND A STAFF MEMBER ACCIDENTALLY UNPLUGGED THE MACHINE. THE ANESTHESIOLOGIST HAD TROUBLE ESTABLISHING AN AIRWAY AND THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448457 FLUIDSMART FLUID MANAGEMENT SYSTEM INSUFFLATOR, HYSTEROSCOPIC HIG STRYKER ENDOSCOPY-SAN JOSE P2000 00860936000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death