STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), HAS BEEN SCHEDULED. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS NOVEMBER 17, 2015 WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF SEPTEMBER 24, 2016 FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT YET REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME.

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 64-YEAR-OLD MALE UNDERGOING A CT SCAN OF THE CHEST HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE INJECTION, THE CUSTOMER REPORTED THAT AN ESTIMATED 20 ML OF AIR WAS OBSERVED ON THE DISPLAYED IMAGES. THE PATIENT WAS THEN PLACED IN TRENDELENBURG POSITION AND TRANSFERRED TO THE INTENSIVE CARE UNIT FOR HYPERBARIC CHAMBER TREATMENT. THE PATIENT HAD BEEN ASYMPTOMATIC THROUGHOUT THE EVENT AND WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS NOVEMBER 17, 2015, WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF (B)(6) 2016 FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT YET REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME.

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 64-YEAR-OLD MALE UNDERGOING A CT SCAN OF THE CHEST HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE INJECTION, THE CUSTOMER REPORTED THAT AN ESTIMATED 20 ML OF AIR WAS OBSERVED ON THE DISPLAYED IMAGES. THE PATIENT WAS THEN PLACED IN TRENDELENBURG POSITION AND TRANSFERRED TO THE INTENSIVE CARE UNIT FOR HYPERBARIC CHAMBER TREATMENT. THE PATIENT HAD BEEN ASYMPTOMATIC THROUGHOUT THE EVENT AND WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY.

Additional Manufacturer Narrative

THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS NOVEMBER 17, 2015, WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF (B)(6) 2016 FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT YET REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME.

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 64-YEAR-OLD MALE HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE INJECTION, THE CUSTOMER REPORTED THAT AN ESTIMATED 20 ML OF AIR WAS OBSERVED ON THE DISPLAYED IMAGES. THE PATIENT WAS THEN PLACED IN TRENDELENBURG POSITION, TRANSFERRED TO THE INTENSIVE CARE UNIT, AND RECEIVED TREATMENT IN A HYPERBARIC CHAMBER. THE PATIENT HAD BEEN ASYMPTOMATIC THROUGHOUT THE EVENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.