VITAL SIGNS¿ ADULT ANESTHESIA BREATHING CIRCUIT

Additional Manufacturer Narrative

AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT EXPERIENCED AN ADVERSE EVENT WHILE CONNECTED TO SKU: AMY520X4F PRODUCT: VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT. THE CUSTOMER SAID THAT THE PATIENT SUSTAINED TETANUS UPON COMPLETING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE ATTENDING ANESTHESIOLOGIST PAGED HIS TEAM TO NOTIFY THEM OF THE "WAKING UP" PATIENT. THE PATIENT REMAINED ON THE VENTILATOR, WAITING TO RETURN TO SPONTANEOUS VENTILATION. THE PATIENT SUDDENLY WOKE UP, AND THE TEAM IMMEDIATELY REMOVED THE PATIENT FROM THE VENTILATOR AND PROVIDED POSITIVE PRESSURE VENTILATION VIA A BAG-MASK VALVE. MINIMAL ETCO2 WAS NOTED WITH SMALL TIDAL VOLUMES. THE CLINICIANS STATED THAT THEY COULD NOT MAINTAIN ANY PRESSURE FROM THE BAG. THE CLINICIANS CHECKED FOR A CIRCUIT LEAK, BUT NONE WERE FOUND, AND THE PATIENT WAS PLACED BACK ON THE VENTILATOR. THE PATIENT'S SATURATION BEGAN TO DROP, AND THEIR HEART RATE DECREASED TO THE '30S. THE STAFF DECIDED TO BEGIN CHEST COMPRESSIONS AND GIVE THE PATIENT THE NECESSARY DRUGS TO RAISE ALL VITAL SIGNS. THE PHYSICIAN NOTICED THAT THE CIRCUIT HME FILTER WAS STICKING OUT OF THE END OF THE REINFORCED ENDOTRACHEAL TUBE. THE HME FILTER WAS WITHDRAWN, THE CIRCUIT WAS RECONNECTED, AND THE TEAM COULD IMMEDIATELY VENTILATE THE PATIENT. THE PATIENT'S VITAL SIGNS BEGAN TO IMPROVE SLOWLY. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY FURTHER HARM OR INJURY.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION:THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION AND IT WAS OBSERVED FILTER PART NUMBER R8004231 (USED TO MANUFACTURE THE FG AMY520X4F), THIS FILTER WAS RECEIVED WITH THE MEDIA SPONGE DETACHED AND OPENED. SAMPLE WAS EVALUATED ACCORDING TO OUR INTERNAL PROCEDURES AND A DEFECT COULD BE OBSERVED. THEREFORE, THE DEFECT REPORTED BY THE CUSTOMER WAS CONFIRMED. IT WAS DETERMINED THAT THE MATERIAL MAY BE RELATED WITH THE REPORTED DEFECT SINCE THE MINI FILTER IS NOT MANUFACTURED AT VYAIRE MEDICAL. ALTHOUGH INCOMING INSPECTION PERSONNEL PERFORM AN INSPECTION ACCORDING TO RMQAS R8004231, BUT THIS INSPECTION IS ONLY A SAMPLING. ADDITIONALLY PFMEA 58A WAS REVIEWED AND WE HAVE THE CONTROLS FOR THIS KIND OF ISSUE.