Description of Event or Problem · 1
THIS DEVICE PROVIDES AN AIRWAY TO CRITICALLY ILL EXTREMELY LOW BIRTH WEIGHT PREMATURE NEWBORNS. THE PRODUCT ATTACHES TO A MECHANICAL VENTILATOR TO PROVIDE O2 AND LIFE SUPPORT. IN THE LAST 6 MONTHS, WE HAVE HAD A TOTAL OF 5 ISSUES WITH THIS DEVICE. A PREVIOUS DEVICE REPORT WAS SUBMITTED. AT THE TIME OF THE PREVIOUS REPORT, THE SUSPECTED DEVICE LOT NUMBERS WERE REMOVED FROM OUR FACILITY'S SHELVES. THE MANUFACTURER SENT REPLACEMENT PRODUCT, BUT IT WAS FROM THE SAME LOT NUMBER. THE PROBLEM CONTINUES DESPITE THIS EFFORT.WHEN ATTEMPTING TO PASS A 6 FR SUCTION CATHETER TUBE DOWN THE ETT, IT WAS NOT ABLE TO PASS THE END OF THE TRACHEAL TUBE. IT FELT AS IF THE ETT WAS PINCHED AT THE END, RESULTING IN OCCLUSION. DIFFERENT SUCTION TUBES WERE USED TO ASSURE THAT IT WAS NOT THE SUCTION TUBING, AND THE SAME THING OCCURRED. THE NEONATES INVOLVED DEMONSTRATED AN INCREASED NEED IN F102 REQUIREMENTS. THE NEONATES NEEDED TO BE REINTUBATED, THEREFORE PUTTING THE BABIES THROUGH AN UNNECESSARY ADDITIONAL PROCEDURE AND POSSIBLE DELAYS IN TREATMENT. THERE ARE NO PATIENT FACTORS ATTRIBUTED TO THESE EVENTS.THE STAFF WERE ABLE TO DUPLICATE THIS TYPE OF PROBLEM OUTSIDE OF THE PATIENT WITH THE SAME RESULT. THE SUCTION CATHETER WOULD NOT PASS THROUGH THE ETT FOR THIS LOT NUMBER. STAFF REPORTED THAT THE SENSATION OF FEELING THE ETT WAS PINCHED WAS THE SAME WHEN THE DEVICE WAS IN A PATIENT AS WHEN IT WAS NOT.THE NURSE MANAGER HAS BEEN IN CLOSE CONTACT WITH THE MANUFACTURER REGARDING THIS PROBLEM. MANUFACTURER REP TOLD THE NURSE MANAGER THAT THEY HAVE HAD THIS SAME PROBLEM WITH THIS DEVICE AT ANOTHER FACILITY. OUR FACILITY HAS PULLED ALL OF THIS MANUFACTURER'S PRODUCT OFF OF OUR SHELVES AGAIN.======================MANUFACTURER RESPONSE FOR HUDSON RCI/SHERIDAN UNCUFFED 2.5 ETT, HUDSON RCI/SHERIDAN UNCUFFED 2.5 ETT (PER SITE REPORTER).======================TELEFLEX MEDICAL WAS CONTACTED SEVERAL MONTHS AGO AND INFORMED THAT THERE WAS PROBLEMS WITH THE DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PROVIDE AN AIRWAY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #4IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.