DISP MANUAL RESUS,ADULT W/FLOW DIVERTER

Additional Manufacturer Narrative

QN#(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "PATIENT UNDERWENT CARDIAC SURGERY, WHICH WAS UNEVENTFUL. WHEN PREPARING TO TRANSPORT THE PATIENT FROM THE OPERATING ROOM TO THE ICU, THE ENDOTRACHEAL TUBE WAS ATTACHED TO A LIFESAVER HUDSON RCI MANUAL RESUSCITATOR. IT WAS IMMEDIATELY DIFFICULT TO VENTILATE THE PATIENT AND REQUIRED EXTREMELY HIGH PEAK PRESSURES TO VENTILATE. THE PATIENT RAPIDLY BECAME HYPOTENSIVE AND BRADYCARDIC WITH MEAN ARTERIAL PRESSURES IN THE 30S AND HEART RATE IN THE 40S. THE PATIENT WAS PLACED BACK ON THE ANESTHESIA MECHANICAL VENTILATOR AND WAS VENTILATED WITHOUT DIFFICULTY. WHEN THE HUDSON RCI RESUSCITATOR BAG WAS EXAMINED, IT WAS FOUND TO HAVE A DEFECTIVE UNIDIRECTIONAL DUCKBILL VALVE WHICH WAS STUCK IN THE OPEN POSITION. THE DEFECTIVE VALVE ALLOWED ONLY INSPIRATORY BREATHS TO BE DELIVERED TO THE PATIENT; IT DID NOT ALLOW THE PATIENT TO EXHALE. BECAUSE OF THE UNIDIRECTIONAL FLOW ALLOWING ONLY INSPIRATION, THE PATIENT DEVELOPED HYPERINFLATION OF THE LUNGS WITH INCREASED INTRATHORACIC PRESSURES WHICH ALMOST RESULTED IN CARDIAC ARREST." ADDITIONAL INFORMATION: "EPINEPHRINE, NOREPINEPHRINE AND CALCIUM CHLORIDE WERE REQUIRED TO TREAT THE RESULTING HYPOTENSION. NO CPR WAS ADMINISTERED, AND ICU STAY/HOSPITALIZATION WAS NOT PROLONGED DUE TO THE DEFECTIVE DEVICE. PATIENT RETURNED TO NORMAL HEMODYNAMICS AFTER BEING PLACED BACK ON THE ANESTHESIA VENTILATOR AND RECEIVING TREATMENT WITH THE VASOACTIVE MEDICATIONS NOTED ABOVE."

Additional Manufacturer Narrative

QN#(B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "UNDER NORMAL OPERATING CONDITIONS, THE PATIENT'S EXHALATION FOLLOWS THIS PATH: THE UNIDIRECTIONAL DUCKBILL VALVE IS CLOSED, ALLOWING AIR TO ENTER THROUGH THE MASK AND EXIT VIA THE 30MM OD PORT. BASED ON THE HOSPITALS FEEDBACK, WE HAVE CONSULTED WITH OUR CLINICAL SPECIALISTS AND R & D STAFF AND DETERMINED THAT ONLY TWO EXTREME SCENARIOS COULD RESULT IN THE ABNORMALITIES THAT THE HOSPITAL REPORTED. WHEN USING A RESUSCITATION BAG, DURING THE PATIENT'S EXHALATION, IF THE RESUSCITATION BAG IS ACCIDENTALLY TOUCHED BY ANOTHER PERSON IN AN EMERGENCY SITUATION THE VALVE IS IN AN OPEN STATE AT THIS TIME. AS A RESULT, THE GAS EXHALED BY THE PATIENT WILL ENTER THE BAG INSTEAD OF BEING EXPELLED THROUGH THE EXHALATION PORT. DURING THE PATIENT'S EXHALATION, THE 33MM OD PORT IS ACCIDENTALLY BLOCKED, LEADING TO IMPAIRED GAS EXPULSION AND CAUSING THE PATIENT TO HAVE DIFFICULTY BREATHING. BASED ON THE ABOVE ANALYSIS AND HISTORICAL SALES DATA, WE HAVE BEEN PRODUCING RESUSCITATION BAG PRODUCTS FOR MORE THAN THREE DECADES, AND THIS IS THE FIRST INSTANCE WHERE WE HAVE ENCOUNTERED FEEDBACK OF THIS NATURE. IT SEEMS TO BE AN ISOLATED OCCURRENCE, POTENTIALLY STEMMING FROM AN UNFORESEEN ACCIDENT DURING USE. GALEMED WILL CONVEY THE CUSTOMER FEEDBACK REGARDING THE ABNORMALITY TO THE ON-SITE STAFF, AND REQUEST THAT THEY PAY ATTENTION TO THIS PHENOMENON IN THE SUBSEQUENT PRODUCTION." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: "PATIENT UNDERWENT CARDIAC SURGERY, WHICH WAS UNEVENTFUL. WHEN PREPARING TO TRANSPORT THE PATIENT FROM THE OPERATING ROOM TO THE ICU, THE ENDOTRACHEAL TUBE WAS ATTACHED TO A LIFESAVER HUDSON RCI MANUAL RESUSCITATOR. IT WAS IMMEDIATELY DIFFICULT TO VENTILATE THE PATIENT AND REQUIRED EXTREMELY HIGH PEAK PRESSURES TO VENTILATE. THE PATIENT RAPIDLY BECAME HYPOTENSIVE AND BRADYCARDIC WITH MEAN ARTERIAL PRESSURES IN THE 30S AND HEART RATE IN THE 40S. THE PATIENT WAS PLACED BACK ON THE ANESTHESIA MECHANICAL VENTILATOR AND WAS VENTILATED WITHOUT DIFFICULTY. WHEN THE HUDSON RCI RESUSCITATOR BAG WAS EXAMINED, IT WAS FOUND TO HAVE A DEFECTIVE UNIDIRECTIONAL DUCKBILL VALVE WHICH WAS STUCK IN THE OPEN POSITION. THE DEFECTIVE VALVE ALLOWED ONLY INSPIRATORY BREATHS TO BE DELIVERED TO THE PATIENT; IT DID NOT ALLOW THE PATIENT TO EXHALE. BECAUSE OF THE UNIDIRECTIONAL FLOW ALLOWING ONLY INSPIRATION, THE PATIENT DEVELOPED HYPERINFLATION OF THE LUNGS WITH INCREASED INTRATHORACIC PRESSURES WHICH ALMOST RESULTED IN CARDIAC ARREST." ADDITIONAL INFORMATION: "EPINEPHRINE, NOREPINEPHRINE AND CALCIUM CHLORIDE WERE REQUIRED TO TREAT THE RESULTING HYPOTENSION. NO CPR WAS ADMINISTERED, AND ICU STAY/HOSPITALIZATION WAS NOT PROLONGED DUE TO THE DEFECTIVE DEVICE. PATIENT RETURNED TO NORMAL HEMODYNAMICS AFTER BEING PLACED BACK ON THE ANESTHESIA VENTILATOR AND RECEIVING TREATMENT WITH THE VASOACTIVE MEDICATIONS NOTED ABOVE."