EDI CATHETER ENFIT 8FR/100 CM, 5PCS

Additional Manufacturer Narrative

LOT # UNKNOWN, THEREFORE NO UDI OR MANUFACTURE DATE AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH A TRACHEOSTOMY AND SEVERE BPD (BRONCHOPULMONARY DYSPLASIA), RECEIVING VENTILATORY SUPPORT IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE WITH AN EDI CATHETER IN PLACE, EXHIBITED INCREASED WORK OF BREATHING AND AN INCREASED OXYGEN REQUIREMENT UP TO 60%. BLOOD GAS ANALYSIS REPORTEDLY SHOWED AN ELEVATED PACO2 LEVEL. IN ADDITION, CHANGES IN THE EDI WAVEFORMS WERE OBSERVED, LEADING THE USER TO SUSPECT THAT THE EDI CATHETER WAS NOT FUNCTIONING AS EXPECTED. THE EDI CATHETER WAS REPLACED, AND THE PATIENT'S CONDITION REPORTEDLY IMPROVED THEREAFTER. THE REMOVED EDI CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ADVERSE PATIENT OUTCOME OR INJURY WAS REPORTED. MANUFACTURER¿S REF #: (B)(4).