SUNMED LLC

Description of Event or Problem

PATIENT PRESENTATION: AN SEMI-RESPONSIVE/CONFUSED PATIENT, FROM A HIGH SPEED MOTORCYCLE ACCIDENT, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 6, 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 SUNMED (AF1100MB-P) MANUAL RESUSCITATOR 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 SUNMED 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 17:22.05 (FIGURE 1) AND PEAKED AT 40 MMHG AT 17:23.30 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 10 AND 35 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO A VENTILATOR AT 17:24.38. 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 FICO2 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" REGARDING PART AF1100MBP WAS NOT CONFIRMED BECAUSE NO PHOTO OR SAMPLE WAS RETURNED. THE ROOT CAUSE CANNOT BE DETERMINED BUT COULD POSSIBLY BE A RESULT OF "DESIGN - TOO MUCH DEAD SPACE BETWEEN PATIENT AND ATMOSPHERE". A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAS BEEN 1 OTHER COMPLAINT AGAINST THIS PART IN THE 24 MONTHS PRECEDING THIS COMPLAINT. THAT COMPLAINT WAS REGARDING THE SAME ISSUE. A RESOLUTION LETTER WAS NOT REQUESTED BY THE CUSTOMER.

Description of Event or Problem

PATIENT PRESENTATION: AN SEMI-RESPONSIVE/CONFUSED PATIENT, FROM A HIGH SPEED MOTORCYCLE ACCIDENT, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 6, 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 SUNMED (AF1100MB-P) MANUAL RESUSCITATOR 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 SUNMED 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 17:22.05 (FIGURE 1) AND PEAKED AT 40 MMHG AT 17:23.30 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 10 AND 35 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO A VENTILATOR AT 17:24.38. 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 FICO2 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.