BRAND NAME: CONNECTING TUBE; NONINVASIVE TUBING. COMMON DEVICE NAME: VACUUM-POWERED BODY FLUID SUCTION APPARATUS. (B)(6). ALTHOUGH REQUESTED THE PRODUCT LOT NUMBER COULD NOT BE PROVIDED. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
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Patient 1
IT WAS REPORTED A ?PATIENT WITH SERIOUS COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) AND TREATED WITH OXYGEN IN THE HOME WAS ADMITTED TO (B)(6) HOSPITAL ON (B)(6) 2017.? ON THE EVENING OF (B)(6) 2017 AT APPROXIMATELY 22:00PM, IT WAS NOTED THE PATIENT EXPERIENCED ABDOMINAL PAIN. THE NURSE REPORTED THAT WHEN SHE LEFT THE ROOM TO GET PAINKILLERS, SHE RETURNED TO FIND THAT THE PATIENT WAS UNCONSCIOUS AND HEAVILY SWOLLEN THROUGHOUT THE BODY. THEY REPORTED THAT THE PATIENT HAD BLEEDING FROM THE RIGHT EAR AND HAD GENERAL SUBCUTANEOUS EMPHYSEMA. THE PATIENT WAS DECLARED DEAD. ?WHEN THE BODY IS PUT IN ORDER IT IS DISCOVERED THAT THE OXYGEN LINE HAD BEEN CONNECTED TO THE URINARY TRACT CATHETER?. THE REPORTED OFFICIAL CAUSE OF DEATH WAS DUE TO AIR EMBOLISM. ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL AND PHYSICIAN, CONFIRMED THE PATIENT WAS IN A SINGLE ROOM, AND THE OXYGEN SOURCE WAS PLACED AT THE RIGHT SIDE BEHIND THE BED AT THE WALL APPROXIMATELY 120 METERS FROM THE FLOOR. THE CATHETER WAS CONFIRMED TO BE LOCATED AT THE BOTTOM OF THE BED. IT WAS STATED THAT ?THEY DON?T KNOW IF THE PATIENT OR THE STAFF CONNECTED THE OXYGEN TUBE WITH THE CATHETER.? THE REPORTER NOTED THAT THE PRODUCT WAS HANDLED THE WRONG WAY AND WAS USED FOR THE WRONG PURPOSE.