MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. STELLAT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	85631829
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the stellant ct injector, serial number (b)(6), was completed on (b)(6)2023, which confirmed that the injector was operating within bayer specifications.The disposables that were in use during the event are being returned for a full evaluation.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.
Event or Problem Description
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® stellant 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 transferred to the emergency department at which time a thoracic surgeon was consulted.After being evaluated by the thoracic surgeon, the patient was confirmed to be fine and was subsequently discharged to home with no further issues reported.Bayer medical care received a medwatch (mw5117517) on may 22, 2023.
Additional Manufacturer Narrative
A system service check of the stellant ct injector (serial number (b)(6)) was completed on may 8, 2023, which confirmed that the injector was operating within bayer specifications.There was no evidence of equipment malfunction.Bayer product analysis received and examined the returned contrast syringe and low-pressure connector tubing (lpct) that were in use at the time of the reported issue.Visual examination identified and confirmed deformation of the syringe tip consistent with twisting that occurs due to overtightening of the spike during the filling process.As the tip was damaged upon receipt, functional testing of the returned products was not possible.The damaged syringe tip was most likely caused by overtightening of the spike during the filling process and should have been observed prior to connection of the lpct.Our investigation concluded the user should have observed the issue upon removal of the spike and replaced the syringe in order to mitigate the reported symptom as prescribed within the system operation manual and disposables instructions for use (ifu).The customer indicated that they regularly prime the lpct with the injector head in the downward position; however, the stellant ct disposables ifu prescribes that the injector head should be facing upward during the filling and priming process in order to expel all air from the disposables and to ensure that a successful connection is made prior to patient connection.The stellant ct injection system operation manual cautions the user as follows: warning: air embolization can cause death or serious injury to the patient.Do not connect a patient to the injector until all trapped air has been cleared from the syringe and fluid path.Additionally, the stellant ct disposables ifu states: operator vigilance and care, coupled with a set procedure, is essential to minimizing the possibility of an air embolism.Point the injector head up during loading.Point the injector head down during an injection.The customer 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.

• Brand Name: STELLAT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 17003574
• Report Number: 2520313-2023-00014
• Device Sequence Number: 7126591
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K192370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 85631829
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLEXD-150-SPK - LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male