STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

ON FEBRUARY 28, 2025, BAYER MEDICAL CARE WAS INFORMED THAT THE POLICE HAVE SEALED THE ROOM AT THE HOSPITAL. THEREFORE, AN INVESTIGATION OF EQUIPMENT AND/OR DISPOSABLES CANNOT BE PERFORMED AT THIS TIME. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN ALLEGED AIR INJECTION AND SUBSEQUENT PATIENT DEATH OCCURRED WHILE A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)) WAS IN USE. A REQUEST FOR ADDITIONAL INFORMATION, INCLUDING AN AUTOPSY REPORT AND/OR CAUSE OF DEATH REPORT, HAS BEEN MADE. HOWEVER, THE HOSPITAL INDICATED THAT A POLICE INVESTIGATION WAS UNDERWAY AND THEREFORE, LIMITED INFORMATION IS AVAILABLE AT THIS TIME.

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN ALLEGED AIR INJECTION AND SUBSEQUENT PATIENT DEATH OCCURRED WHILE A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)) WAS IN USE. A REQUEST FOR ADDITIONAL INFORMATION, INCLUDING AN AUTOPSY REPORT AND/OR CAUSE OF DEATH REPORT, HAS BEEN MADE. HOWEVER, THE HOSPITAL INDICATED THAT A POLICE INVESTIGATION WAS UNDERWAY AND THEREFORE, LIMITED INFORMATION IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

ON JULY 17, 2025, BAYER MEDICAL CARE WAS INFORMED THAT THE MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)) HAS NOT BEEN RELEASED FOR EVALUATION. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT, INCLUDING DISPOSABLE INFORMATION; HOWEVER, THOSE ATTEMPTS HAVE BEEN UNSUCCESSFUL. THEREFORE, AN INVESTIGATION OF THE EQUIPMENT AND/OR DISPOSABLES CANNOT BE CARRIED OUT. OUR INVESTIGATION CONCLUDED THAT THERE IS INSUFFICIENT EVIDENCE OF PRODUCT MALFUNCTION OR THE FAILURE OF THE DEVICE TO MEET SPECIFICATION. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Additional Manufacturer Narrative

A BAYER SERVICE INJECTOR SYSTEM CHECKOUT, AS WELL AS A REQUEST FOR THE RETURN OF THE DISPOSABLES AND/OR LOT NUMBERS USED IN THE REPORTED INCIDENT, HAS BEEN MADE AND IS AWAITING THE CUSTOMER RESPONSE. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN ALLEGED AIR INJECTION AND SUBSEQUENT PATIENT DEATH OCCURRED WHILE A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)) WAS IN USE. A REQUEST FOR ADDITIONAL INFORMATION, INCLUDING AN AUTOPSY REPORT AND/OR CAUSE OF DEATH REPORT, HAS BEEN MADE. HOWEVER, THE HOSPITAL INDICATED THAT A POLICE INVESTIGATION WAS UNDERWAY AND THEREFORE, LIMITED INFORMATION IS AVAILABLE AT THIS TIME.