SUNMED LLC

Description of Event or Problem

PATIENT PRESENTATION: AN UNRESPONSIVE PATIENT, SUFFERING FROM A FOUR-STORY FALL, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 5, INDICATIVE OF SEVERE CONSCIOUSNESS IMPAIRMENT. MEDICAL INTERVENTIONS: RAPID SEQUENCE INTUBATION (RSI) WAS PERFORMED TO ESTABLISH AIRWAY PATENCY. THE ENDOTRACHEAL TUBE (ETT) WAS VENTILATED WITH A SMALL ADULT CURAPLEX (2422-BVMPSA) MANUAL RESUSCITATOR WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 15 CMH2O, IN-LINE END-TIDAL CO2 (ETC02) 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 15:56.24 (FIGURE 1) AND PEAKED AT 35 MMHG AT 15:58.03 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 20 AND 35 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO AN AMBU MANUAL RESUSCITATOR AT 15:58.46. 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.

Additional Manufacturer Narrative

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" WAS CONFIRMED TO BE ASSOCIATED WITH NCMR-02506. A RESOLUTION LETTER WAS NOT REQUESTED BY THE CUSTOMER.

Description of Event or Problem

PATIENT PRESENTATION: AN UNRESPONSIVE PATIENT, SUFFERING FROM A FOUR-STORY FALL, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 5, INDICATIVE OF SEVERE CONSCIOUSNESS IMPAIRMENT. MEDICAL INTERVENTIONS: RAPID SEQUENCE INTUBATION (RSI) WAS PERFORMED TO ESTABLISH AIRWAY PATENCY. THE ENDOTRACHEAL TUBE (ETT) WAS VENTILATED WITH A SMALL ADULT CURAPLEX (2422-BVMPSA) MANUAL RESUSCITATOR WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 15 CMH2O, IN-LINE END-TIDAL CO2 (ETC02) 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 15:56.24 (FIGURE 1) AND PEAKED AT 35 MMHG AT 15:58.03 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 20 AND 35 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO AN AMBU MANUAL RESUSCITATOR AT 15:58.46. 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.

Additional Manufacturer Narrative

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.