STELLANT DUAL CT INJECTOR

Description of Event or Problem

BAYER MEDICAL CARE BECAME AWARE OF AN ALLEGED AIR INJECTION THAT OCCURRED DURING A CT EXAMINATION OF THE CHEST WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). AN 84-YEAR-OLD FEMALE PATIENT UNDERWENT A PULMONARY CT ANGIOGRAM WITH CONTRAST INJECTION FOR EVALUATION OF SUSPECTED PULMONARY EMBOLISM. DURING IMAGE REVIEW, AIR WAS IDENTIFIED IN THE PULMONARY ARTERY TRUNK AND RIGHT ATRIUM, CONSISTENT WITH AN ACCIDENTAL AIR EMBOLISM. RADIOGRAPHERS ALSO OBSERVED CONTRAST AGENT ON THE EXAMINATION TABLE, INDICATING A POSSIBLE LEAK AT A CONNECTION POINT ON THE PERFUSION LINE. THE PATIENT REMAINED ASYMPTOMATIC AND SUBSEQUENTLY RECEIVED A HYPERBARIC CHAMBER SESSION AS A PRECAUTIONARY CLINICAL MEASURE.

Additional Manufacturer Narrative

A BAYER REPRESENTATIVE SPOKE WITH THE SITE'S RADIOLOGY MANAGER, WHO CONFIRMED THAT THE ALLEGED AIR INJECTION WAS NOT ATTRIBUTABLE TO THE MEDRAD® STELLANT INJECTOR SYSTEM BUT TO THE USE OF A THIRD-PARTY PATIENT TUBING ADDED AS AN EXTENSION TO THE MEDRAD® STELLANT DISPOSABLE KIT. SHE REPORTED THAT THE THIRD-PARTY TUBING EXHIBITED VALVE AND CAP DETACHMENT LEADING TO AIR LEAKS AND CONFIRMED THAT THIS WAS THE SOURCE OF THE AIR BUBBLES OBSERVED ON THE CT IMAGES. ACTIONS TAKEN BY THE SITE INCLUDE REPORTING THE THIRD-PARTY TUBING INCIDENT TO THE FRENCH HEALTH AUTHORITY IN ACCORDANCE WITH VIGILANCE REQUIREMENTS, INSTRUCTING STAFF TO DISCONTINUE THE SUSPECT THIRD PARTY EXTENSION SETS, AND REVIEWING THE APPROPRIATE USE AND PROPER PURGING TECHNIQUES FOR BAYER SUPPLIED DISPOSABLES. THE CUSTOMER CONTINUES TO USE THE MEDRAD® STELLANT INJECTOR SYSTEM AND HAS DECLINED BAYER'S OFFER OF AN INJECTOR CHECKOUT AND ADDITIONAL CLINICAL APPLICATIONS TRAINING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE MEDRAD® STELLANT INJECTOR SYSTEM WAS MANUFACTURED IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS, WITH NO IDENTIFIED DEVIATIONS, NONCONFORMANCES, FAILURES, OR QUALITY RELATED ISSUES. THE MEDRAD® STELLANT OPERATIONS MANUAL INCLUDES THE FOLLOWING WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. USE ONLY DISPOSABLES OR ACCESSORIES SUPPLIED BY BAYER. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS MAY 28, 2014, WHICH PREDATES THE UDI IMPLEMENTATION DEADLINE OF S(B)(6) 2016, FOR CLASS II DEVICES. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.