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 PATIENT BEGAN HIS EMERGENCE FROM THE GENERAL ANESTHETIC IN A VERY ROBUST MANNER; ALMOST IMMEDIATELY, HIS OXYGEN SATURATION, BLOOD PRESSURE, AND HEART RATE BEGAN TO FALL RAPIDLY. THE ANESTHESIA EMERGENCY BUTTON WAS ACTIVATED, AND SEVERAL FACULTIES ARRIVED QUICKLY. WHILE PROCEDURES WERE BEING DONE, HOSPITAL STAFF DISCONNECTED THE ET TUBE FROM THE VENTILATOR, AND A SUCTION CATHETER WAS PLACED IN THE ET TUBE WITHOUT OBSTRUCTION. AT THIS POINT, WHEN A SECOND RESIDENT WENT TO REATTACH THE VENTILATOR TUBING TO THE ET TUBE, SHE NOTICED A FOREIGN OBJECT LODGED IN THE ELBOW CONNECTER OF THE VENTILATOR TUBING. THE ELBOW WAS IMMEDIATELY REMOVED, THE VENTILATOR TUBING WAS REATTACHED TO THE ET TUBE, AND I WAS ABLE TO VENTILATE THE PATIENT WITHOUT PROBLEMS EFFICIENTLY. HE HAD DEVELOPED A PULSELESS ELECTRICAL ACTIVITY EARLY ON AS HIS SATURATIONS FELL AND HIS BLOOD PRESSURE DROPPED. HE UNDERWENT AGGRESSIVE CPR BY THE OR NURSING. HE HAD A RETURN OF SPONTANEOUS CONTRACTIONS (ROSC) ALMOST IMMEDIATELY AFTER THE PHYSICIAN WAS ABLE TO VENTILATE HIS LUNGS. AFTER THE ELBOW HAD BEEN REMOVED FROM THE VENTILATOR CIRCUIT, THE STAFF EXAMINED THE ELBOW AND PULLED THE FOREIGN BODY FROM THE ELBOW, WHICH WAS TOTALLY OCCLUDED. IT WAS IMMEDIATELY APPARENT THAT THIS OBJECT WAS A FILTER FROM THE VENTILATOR CIRCUIT, AND ON EXAMINATION, INDEED, A FILTER FROM THE HFME FILTER DEVICE WAS MISSING. THE PATIENT WAS TRANSPORTED TO THE ICU INTUBATED. HE WAS EXTUBATED LATER THAT AFTERNOON AND DISCHARGED HOME THE FOLLOWING AFTERNOON. AT HIS TWO-WEEK FOLLOW-UP VISIT WITH HIS SURGEON, HE WAS DOING WELL AND REQUESTED A RELEASE FORM SO HE COULD RETURN TO WORK.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION:NO PICTURES OR PHYSICAL SAMPLE WAS RETURNED FOR INVESTIGATION, SO WE WERE UNABLE TO VERIFY THE REPORTED ISSUE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES WERE FOUND. THEREFORE, THE DEFECT REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.