CENTARGO CT INJECTOR
Report
- Report Number
- 2520313-2025-00019
- Event Type
- Injury
- Date Received
- August 6, 2025
- Date of Event
- July 24, 2025
- Report Date
- September 30, 2025
- Manufacturer
- IMAXEON PTY LTD
- Product Code
- DXT
- PMA / PMN Number
- K241849
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6) WAS COMPLETED ON JULY 28, 2025 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE EVENT WERE DISCARDED BY THE CUSTOMER. THE SPECIFIC LOT NUMBER OF THE DAY SET THAT WAS IN USE WAS NOT KNOWN BY THE CUSTOMER; HOWEVER, THEY DID PROVIDE TWO POTENTIAL BATCH NUMBERS FROM THEIR STOCK (CENT-DS, LOT NUMBERS 8425637 AND 8425354). BAYER PRODUCT ANALYSIS FUNCTIONALLY TESTED A RETAINED SAMPLE FROM CENT-DS, LOT NUMBER 8425637 AND 8425354. FUNCTIONAL TESTING CONCLUDED THAT THE RETAINED DISPOSABLES 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: 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. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6)) HAS BEEN REQUESTED AND WE ARE AWAITING THE RESULTS. WE HAVE ALSO REQUESTED THE SUBJECT DISPOSABLES THAT WERE INVOLVED WITH THIS INCIDENT. AS WE ARE AWAITING THE OUTCOME OF THE INJECTOR EVALUATION AS WELL AS THE RETURN OF THE DISPOSABLES, THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, 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.
A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6) HAS BEEN REQUESTED AND WE ARE AWAITING THE RESULTS. THE CUSTOMER DISCARDED THE SUSPECT DISPOSABLES AT THE TIME OF THE INCIDENT; HOWEVER, THEY WERE ABLE TO PROVIDE A LOT NUMBER FOR THE MEDRAD® CENTARGO DAY SET. THE TESTING OF A RETAINED SAMPLE IS PENDING. ONCE THE EVALUATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS OFFERED; HOWEVER, THE CUSTOMER DECLINED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS PLACED IN A LEFT SIDE DOWN DECUBITUS POSITION AND PLACED ON OXYGEN AS A PRECAUTION. THE PATIENT WAS OBSERVED FOR TWO HOURS POST PROCEDURE AND SUBSEQUENTLY UNDERWENT A REPEAT CT SCAN WHICH CONFIRMED THAT THE AIR HAD RESOLVED. NO FURTHER ISSUES WERE REPORTED.
BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS PLACED IN A LEFT SIDE DOWN DECUBITUS POSITION AND PLACED ON OXYGEN AS A PRECAUTION. THE PATIENT WAS OBSERVED FOR TWO HOURS POST PROCEDURE AND SUBSEQUENTLY UNDERWENT A REPEAT CT SCAN WHICH CONFIRMED THAT THE AIR HAD RESOLVED. NO FURTHER ISSUES WERE REPORTED.
BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS PLACED IN A LEFT SIDE DOWN DECUBITUS POSITION AND PLACED ON OXYGEN AS A PRECAUTION. THE PATIENT WAS OBSERVED FOR TWO HOURS POST PROCEDURE AND SUBSEQUENTLY UNDERWENT A REPEAT CT SCAN WHICH CONFIRMED THAT THE AIR HAD RESOLVED. NO FURTHER ISSUES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1765796 | CENTARGO CT INJECTOR | CT INJECTION SYSTEM | DXT | IMAXEON PTY LTD | 88982797 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Unknown | Other | DAY SET - LOT 8425637 OR 8425354| DAY SET - LOT 8425637 OR 8425354| DAY SET - LOT 8425637 OR 8425354| PATIENT LINE - LOT UNKNOWN| PATIENT LINE - LOT UNKNOWN| PATIENT LINE - LOT UNKNOWN |