CENTARGO CT INJECTOR

Description of Event or Problem

BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE A PATIENT WAS CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, THE CUSTOMER REPORTED THAT THE QUANTITY OF AIR THAT WAS VISUALIZED ON THE DISPLAYED IMAGES COULD NOT BE QUANTIFIED. THE PATIENT WAS PLACED INTO A HYPERBARIC CHAMBER FOR FURTHER CARE AND TREATMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6)) WAS COMPLETED ON (B)(6) 2025 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE EVENT WERE DISCARDED BY THE CUSTOMER. HOWEVER, AS THE CUSTOMER DID PROVIDE THE LOT NUMBER FOR THE DAY SET (CENT-DS, LOT NUMBER 1498374001) THAT WAS IN USE, TESTING OF A RETAINED SAMPLE IS PENDING. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE CUSTOMER CONTINUES TO USE THE MEDRAD® CENTARGO CT INJECTION SYSTEM WITH NO FURTHER ISSUES REPORTED AND HAS DECLINED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. 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

BAYER SERVICE PERFORMED A SYSTEM SERVICE CHECK OUT OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)) ON (B)(6) 2025 WHICH CONFIRMED THAT THE EQUIPMENT WAS OPERATING TO SPECIFICATION. THE CUSTOMER DISCARDED THE DISPOSABLES THAT WERE IN USE AT THE TIME OF THE INCIDENT; HOWEVER, THEY WERE ABLE TO PROVIDE THE LOT NUMBER FOR THE DAY SET. BAYER PRODUCT ANALYSIS FUNCTIONALLY TESTED A RETAINED SAMPLE FROM CENT-DS, LOT NUMBER 1498374001. FUNCTIONAL TESTING CONCLUDED THAT THE RETAINED DISPOSABLE PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE CUSTOMER DECLINED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. THE MEDRAD® CENTARGO CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: THE SYSTEM MUST BE ARMED PRIOR TO PERFORMING ANY INJECTION IN A PROTOCOL. PRESS ARM TO ARM THE SYSTEM. FOR THE FIRST INJECTION OF AN EXAM, A MESSAGE DISPLAYS ASKING FOR CONFIRMATION THE PATIENT LINE HAS BEEN CHECKED FOR AIR · PRESS YES TO CONFIRM ALL AIR HAS BEEN EXPELLED AND NO AIR IS VISIBLE IN THE PATIENT LINE · PRESS NO IF THE PATIENT LINE HAS NOT BEEN CHECKED FOR AIR. THE SYSTEM WILL NOT ARM. WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. DO NOT MODIFY OR ATTEMPT TO CIRCUMVENT THE OPERATION OF THE AIR DETECTORS. DO NOT CONNECT THE PATIENT LINE TO THE PATIENT UNTIL ALL TRAPPED AIR HAS BEEN CLEARED. THE CUSTOMER CONTINUES TO USE THE MEDRAD® CENTARGO CT INJECTION SYSTEM WITH NO FURTHER ISSUES REPORTED AND HAS DECLINED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. 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

BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE A PATIENT WAS CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, THE CUSTOMER REPORTED THAT THE QUANTITY OF AIR THAT WAS VISUALIZED ON THE DISPLAYED IMAGES COULD NOT BE QUANTIFIED. THE PATIENT WAS PLACED INTO A HYPERBARIC CHAMBER FOR FURTHER CARE AND TREATMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Description of Event or Problem

BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE A PATIENT WAS CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, THE CUSTOMER REPORTED THAT THE QUANTITY OF AIR THAT WAS VISUALIZED ON THE DISPLAYED IMAGES COULD NOT BE QUANTIFIED. THE PATIENT WAS PLACED INTO A HYPERBARIC CHAMBER FOR FURTHER CARE AND TREATMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE CUSTOMER CONTINUES TO USE THE MEDRAD® CENTARGO CT INJECTION SYSTEM WITH NO FURTHER ISSUES REPORTED AND HAS DECLINED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.