BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED LLC

    MDR report key: 18592411 · Received January 26, 2024

    Report

    Report Number
    1314417-2024-00005
    Event Type
    Injury
    Date Received
    January 26, 2024
    Date of Event
    June 20, 2023
    Report Date
    January 25, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF ABNORMAL FICO2 ELEVATION. THIS IS THE ISSUE THAT WAS REFERRED TO IN THE FIELD NOTIFICATION INITIATED ON OCT 11, 2023. IN ADDITION, THE FDA MEDWATCH REPORT WAS RECEIVED. THE COMPLAINT OF "THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF ABNORMAL FICO2 ELEVATION" REGARDING PART 2442-BVMPAD WAS CONFIRMED TO BE ASSOCIATED WITH NCMR-02506. A RESOLUTION LETTER WAS NOT REQUESTED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF ABNORMAL FICO2 ELEVATION. THIS IS THE ISSUE THAT WAS REFERRED TO IN THE FIELD NOTIFICATION INITIATED ON OCT 11, 2023. IN ADDITION, THE FDA MEDWATCH REPORT WAS RECEIVED.

    Description of Event or Problem · 0

    PATIENT PRESENTATION: AN UNRESPONSIVE PATIENT, DISCOVERED IN A FIELD AND EXHIBITING HYPERTHERMIA, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 7, INDICATIVE OF SEVERE CONSCIOUSNESS IMPAIRMENT. MEDICAL INTERVENTIONS: RAPID SEQUENCE INTUBATION (RSI) WAS PERFORMED TO ESTABLISH AIRWAY PATENCY. THE ENDOTRACHEAL TUBE (ETT) WAS VENTILATED WITH AN ADULT CURAPLEX (2422-BVMPAD) MANUAL RESUSCITATOR EQUIPPED WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 15 CMH2O, HEAT AND MOISTURE EXCHANGE FILTER (HMFE}, IN-LINE END-TIDAL CO2 (ETCO2) SENSOR AND CONNECTED TO A 15 L/MIN OXYGEN SOURCE. FIC02 ELEVATION ISSUE: WHILE USING THE CURAPLEX MANUAL RESUSCITATOR, THE PATIENT'S FRACTION OF INSPIRED CO2 (FICO2) LEVELS INCREASED UNTIL THE CLINICAL TEAM PLACED THE PATIENT ON A VENTILATOR. THIS INCREASE BEGAN AT 20:09.42 (FIGURE 1) AND REACHED A PEAK OF 22 MMHG AT 20:15.03 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 5 AND 15 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO A VENTILATOR AT 20:19.22. THE ELEVATION IN FICO2 RESOLVED ONCE THE VENTILATOR WAS INITIATED (FIGURE 4). PRODUCT PROBLEM: SUSPICIONS ARISE THAT THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF THE ABNORMAL FIC02 ELEVATION. THE FIC02 INCREASE POSES A RISK OF HYPERCAPNIA, WHICH CAN SIGNIFICANTLY IMPACT THE PATIENT'S BODILY FUNCTIONS, PHYSICAL WELL-BEING, AND POTENTIALLY LEAD TO LIFE-THREATENING CONSEQUENCES. FURTHERMORE, THIS INCONSISTENCY RAISES CONCERNS REGARDING ADHERENCE TO PERFORMANCE SPECIFICATIONS AND USER EXPECTATIONS. PATIENT OUTCOME: THE PATIENTS OUTCOME IS UNKNOWN, AS CARE WAS HANDED OVER TO ANOTHER PROVIDER.

    Description of Event or Problem · 0

    PATIENT PRESENTATION: AN UNRESPONSIVE PATIENT, DISCOVERED IN A FIELD AND EXHIBITING HYPERTHERMIA, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 7, INDICATIVE OF SEVERE CONSCIOUSNESS IMPAIRMENT. MEDICAL INTERVENTIONS: RAPID SEQUENCE INTUBATION (RSI) WAS PERFORMED TO ESTABLISH AIRWAY PATENCY. THE ENDOTRACHEAL TUBE (ETT) WAS VENTILATED WITH AN ADULT CURAPLEX (2422-BVMPAD) MANUAL RESUSCITATOR EQUIPPED WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 15 CMH2O, HEAT AND MOISTURE EXCHANGE FILTER (HMFE}, IN-LINE END-TIDAL CO2 (ETCO2) SENSOR AND CONNECTED TO A 15 L/MIN OXYGEN SOURCE. FIC02 ELEVATION ISSUE: WHILE USING THE CURAPLEX MANUAL RESUSCITATOR, THE PATIENT'S FRACTION OF INSPIRED CO2 (FICO2) LEVELS INCREASED UNTIL THE CLINICAL TEAM PLACED THE PATIENT ON A VENTILATOR. THIS INCREASE BEGAN AT 20:09.42 (FIGURE 1) AND REACHED A PEAK OF 22 MMHG AT 20:15.03 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 5 AND 15 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO A VENTILATOR AT 20:19.22. THE ELEVATION IN FICO2 RESOLVED ONCE THE VENTILATOR WAS INITIATED (FIGURE 4). PRODUCT PROBLEM: SUSPICIONS ARISE THAT THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF THE ABNORMAL FIC02 ELEVATION. THE FIC02 INCREASE POSES A RISK OF HYPERCAPNIA, WHICH CAN SIGNIFICANTLY IMPACT THE PATIENT'S BODILY FUNCTIONS, PHYSICAL WELL-BEING, AND POTENTIALLY LEAD TO LIFE-THREATENING CONSEQUENCES. FURTHERMORE, THIS INCONSISTENCY RAISES CONCERNS REGARDING ADHERENCE TO PERFORMANCE SPECIFICATIONS AND USER EXPECTATIONS. PATIENT OUTCOME: THE PATIENTS OUTCOME IS UNKNOWN, AS CARE WAS HANDED OVER TO ANOTHER PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393427 SUNMED LLC VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR BTM SUNMED HOLDINGS LLC 2422-BVMPAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other