BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION FLOW

    MDR report key: 18377193 · Received December 21, 2023

    Report

    Report Number
    3012971441-2023-00002
    Event Type
    Death
    Date Received
    December 21, 2023
    Date of Event
    December 11, 2023
    Report Date
    December 18, 2023
    Manufacturer
    VAPOTHERM
    Product Code
    BTT
    UDI-DI
    00841737100140
    PMA / PMN Number
    K072845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE FDA DEFINITION OF A REPORTABLE EVENT AS DEFINED IN 21 CFR 803, VAPOTHERM HAS DETERMINED THAT THIS COMPLAINT DID NOT MEET THE DEFINITION OF REPORTABLE, PER THE RATIONALE PROVIDED BELOW. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION VAPOTHERM IS VOLUNTARILY REPORTING THIS EVENT TO THE FDA SINCE THIS EVENT INVOLVED PATIENT DEATH. THE PATIENT WAS RECEIVING SUPPLEMENTAL OXYGEN FROM THE VAPOTHERM DEVICE AT THE TIME OF THE INCIDENCE. THE INFORMATION GATHERED ON THIS EVENT ALLEGED INITIALLY THAT THE UNIT WAS ALARMING FOR GENERAL FAUL ALARM (GFA) WITH IN O2 WHILE THE PATIENT EVENT OCCURRED. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT'S CONDITION WAS DETERIORATING (LOW BLOOD O2 SATURATION IN THE 80S) BEFORE BEING PLACED ON THE PRECISION FLOW DEVICE. THE PATIENT WAS PLACED ON A NON-REBREATHER MASK AFTER THE ALARM. THE PATIENT WAS ON DO NOT RESUSCITATE (DNR) AND DO NOT INTUBATE (DNI) STATUS AND THEREFORE THE DECISION WAS MADE FOR NO FURTHER THERAPY BEING ADMINISTERED TO THE PATIENT. THE DEVICE WAS NOT MADE AVAILABLE FOR INVESTIGATION. THE DEVICE PERFORMED AS INTENDED AND ALARMED APPROPRIATELY. THE ALARM FOR GFA WITH IN O2 INDICATES AN INCORRECT MIX OF OXYGEN IN THE MEDICAL GASSES SUPPLIED BY THE PF-UNIT. WHEN THIS ALARM OCCURS, THE USER IS INSTRUCTED TO DISCONNECT THE PATIENT AND SHUT OFF THE UNIT. THE DEVICE LABELING ALSO WARNS THAT THIS IS NOT A LIFE SUPPORTING DEVICE. THE TYPICAL USE ENVIRONMENT WILL HAVE ALTERNATE DEVICES/THERAPIES AVAILABLE SUCH AS OTHER RESPIRATORY SUPPORT DEVICES, VENTILATORS AND MANUAL BREATHING DEVICES, IF REQUIRED. IF A PATIENT'S CONDITION DETERIORATES IT WOULD BE STANDARD OF CARE TO SEEK ALTERNATE THERAPY AS INDICATED BY THE DETAILS OF THE COMPLAINT. THE PATIENT CONDITION WAS DETERIORATING EVEN PRIOR TO THERAPY BEING COMMENCED ON THE VAPOTHERM DEVICE. AFTER THE VAPOTHERM THERAPY WAS DISCONTINUED AND A MORE AGGRESSIVE ALTERNATE THERAPY WAS NOT CHOSEN DUE TO THE PATIENT BEING ON DNI/DNR STATUS. PER VAPOTHERM'S INSTRUCTION FOR USE, PATIENTS RECEIVING SUPPLEMENTAL OXYGEN ARE ACUTE AND APPROPRIATE CLINICAL VIGILANCE SHOULD BE OBSERVED BY THE CARE TEAM. ADDITIONAL PATIENT MONITORING INCLUDING PULSE OXIMETRY IS NECESSARY IF THE PRECISION FLOW IS USED TO GIVE SUPPLEMENTARY OXYGEN. IF A PATIENT'S CONDITION DETERIORATES, AND THEY SPONTANEOUSLY DECOMPENSATE TO WHERE THEY ARE NO LONGER SPONTANEOUSLY BREATHING, ESCALATION OF THE THERAPY TO MORE AGGRESSIVE RESPIRATORY SUPPORT (I.E. INTUBATION WITH MECHANICAL VENTILATION), WOULD BE CONSIDERED STANDARD OF CARE. ASSISTED BREATHING (I.E. "BEING BAGGED") IS USUAL AND CUSTOMARY CARE FOR THIS PATIENT POPULATION. THIS POTENTIAL COURSE OF CARE IS NOT UNANTICIPATED. GIVEN THE STANDARD OF CARE WAS NOT FOLLOWED DUE TO THE DNR/DNI STATUS THIS HAS LED TO PATIENT DEATH. 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 RECEIVED AND LOGGED BY VAPOTHERM ON (B)(6) 2023. DEVICE SERIAL NUMBER (B)(6). THE PATIENT INCIDENCE WAS REPORTED TO VAPOTHERM ON THE PRECISION FLOW UNIT WITH SERIAL NUMBER (B)(6). THE PATIENT WAS PLACED ON A NON REBREATHER MASK AND HAD A BLOOD OXYGEN SATURATION IN THE 80S. THE PATIENT WAS PLACED ON THE PRECISION FLOW UNIT WITH BLOOD OXYGEN SATURATION IN "LOW 80S". THE UNIT WAS BEING OPERATED AT 100% FIO2 AT 40 LPM (MAX) FLOW SETTING. AFTER TREATMENT ON THE UNIT FOR A PERIOD OF TIME IT WAS INITIALLY STATED THAT THE UNIT ALARMED FOR A IN THE FIO2 SETTING WITH A GENERAL FAULT ALARM. THERE WAS NO FLOW FROM THE DEVICE WHILE THE ALARM WAS PRESENT. SUBSEQUENTLY, THE PATIENT'S O2 SATURATION DROPPED INTO THE 70'S AND THE PATIENT WAS PLACED ON A NON-REBREATHER MASK. PATIENT WAS DNR/DNI AND THE PATIENT'S FAMILY DECLINED PLACING THE PATIENT ON A MORE AGGRESSIVE ALTERNATE THERAPY. THE PATIENT'S BLOOD O2 SATURATION DECLINED FURTHER AND THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168506 PRECISION FLOW VAPOTHERM PRECISION FLOW BTT VAPOTHERM PRECISION FLOW 00841737100140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death