BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOFT HI-VNI NASAL CANNULAS

    MDR report key: 20159157 · Received September 6, 2024

    Report

    Report Number
    3012971441-2024-00002
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 5, 2024
    Manufacturer
    VAPOTHERM
    Product Code
    QAV
    PMA / PMN Number
    DEN170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER'S REPORT, THE VAPOTHERM PRECISION FLOW SYSTEM, ALONG WITH THE NASAL CANNULA, WAS USED TO PROVIDE END-OF-LIFE COMFORT CARE FOR A PATIENT OVER AN EXTENDED PERIOD OF 124 DAYS. DUE TO THE CONTINUOUS USE OF THE CANNULA FOR MORE THAN FOUR MONTHS, THE PATIENT DEVELOPED SKIN BREAKDOWN (PRESSURE ULCERS) ON THE EAR, WHERE THE CANNULA WAS POSITIONED. VAPOTHERM IS REPORTING THIS INCIDENT AS A SERIOUS INJURY IN COMPLIANCE WITH 21 CFR 803. THIS IS AN ISOLATED CASE OF THE CANNULA CAUSING SEVERE PRESSURE ULCERS. SINCE 2020, VAPOTHERM HAS SHIPPED HUNDREDS OF THOUSANDS OF PROSOFT CANNULAS, AND THIS IS THE ONLY REPORTED CASE OF A SERIOUS SKIN INJURY. PROSOFT CANNULAS ARE SPECIFICALLY DESIGNED TO BE SOFTER THAN STANDARD RESPIRATORY NASAL CANNULAS, WITH THE AIM OF REDUCING THE RISK OF SKIN ULCERS DURING PROLONGED USE. THE PROSOFT NASAL CANNULAS WERE DEVELOPED WITH THE INHERENT RISK OF PRESSURE ULCERS CONSIDERED AS PART OF RISK MANAGEMENT ACTIVITIES. CLINICIANS ARE AWARE OF THE POTENTIAL RISK OF PRESSURE ULCERS ASSOCIATED WITH NASAL CANNULAS [1], [2]. VAPOTHERM HAS NOT RECEIVED ANY OTHER COMPLAINTS RELATED TO PRESSURE ULCERS THROUGHOUT THE HISTORY OF THE PROSOFT CANNULA, LIKELY DUE TO THE PRODUCT'S DESIGN AND THE HEIGHTENED AWARENESS OF CAREGIVERS REGARDING THIS KNOWN RISK. ALTHOUGH THE CANNULA INVOLVED IN THIS INCIDENT COULD NOT BE RETRIEVED FOR INVESTIGATION, NO OBVIOUS MALFUNCTION OF THE DEVICE WAS REPORTED BY THE CAREGIVER. BASED ON THE INFORMATION GATHERED, THE VAPOTHERM PROSOFT CANNULA CONTINUES TO PERFORM WITHIN THE EXPECTATIONS FOR RISK MANAGEMENT ACTIVITIES. [1] BLACK J, KALOWES P. MEDICAL DEVICE-RELATED PRESSURE ULCERS. CHRONIC WOUND CARE MANAGEMENT AND RESEARCH VOLUME 3; 29 AUGUST 2016 VOLUME 2016:3 PAGES 91 - 99. [2] LUKOSE, MOLYKUTTY ET AL. NO MORE SORE EARS: NASAL CANNULA RELATED PRESSURE ULCERS DOWN TO ZERO. WOCN SOCIETY'S 49TH ANNUAL CONFERENCE, 2017. SUBMISSION OF THIS MEDICAL DEVICE REPORT AND THE FDA'S RELEASE OF THAT INFORMATION IS NOT AN ADMISSION THAT PRODUCT, USER FACILITY, DISTRIBUTOR, MANUFACTURER, OR MEDICAL PERSONNEL CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    THE FOLLOWING COMPLAINT WAS LOGGED WITH VAPOTHERM ON (B)(6) 2024. ON 9TH AUGUST 2024 VAPOTHERM RECEIVED AN INITIAL REPORT OF A CASE OF SKIN BREAKDOWN IN CONNECTION WITH THE VAPOTHERM NASAL CANNULA (PROSOFT), USED TO DELIVER HIGH-VELOCITY RESPIRATORY THERAPY WITH THE PRECISION FLOW DEVICE. ON 30TH AUGUST 2024 VAPOTHERM RECEIVED ADDITIONAL INFORMATION THAT THE NASAL CANNULA, OR MULTIPLE CANNULAS, WERE USED ON AN ADULT PATIENT FOR AN EXTENDED PERIOD OF 124 DAYS. THE PATIENT WAS UNDER DO NOT RESUSCITATE (DNR) AND DO NOT INTUBATE (DNI) ORDERS, WITH THE VAPOTHERM DEVICE AND NASAL CANNULA BEING USED FOR COMFORT CARE. THE PROSOFT NASAL CANNULA WAS BEING USED ALONG WITH A NON-REBREATHER MASK. PROLONGED USE OF THE NASAL CANNULA LED TO A GRADE 4 SKIN BREAKDOWN ON THE PATIENT'S EAR(S). NO MEDICAL INTERVENTION WAS PERFORMED FOR THE SKIN BREAKDOWN, AS THE PATIENT WAS RECEIVING END-OF-LIFE CARE. VAPOTHERM WAS INFORMED THAT THERE WAS PATIENT DEATH BUT IT WAS UNRELATED TO THE SKIN BREAKDOWN EVENT. THE DISPOSABLE CANNULA NUMBER OR THE DEVICE SERIAL NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864830 PROSOFT HI-VNI NASAL CANNULAS PROSOFT CANNULA QAV VAPOTHERM PROSOFT HI-VNI NASAL CANNULA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other