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

Model Number	85577026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer medical care inc.Was informed that an 87-year-old female undergoing a ct scan of the chest suffered an alleged air injection while connected to a medrad® stellant flex injection system (sn (b)(6)).After receiving an undisclosed amount of air, the patient complained of shortness of breath with decreasing oxygen saturation.Supplemental oxygen was administered, and the patient was transferred to the emergency department for further care.The patient was subsequently discharged and was reported to be doing well with no further issues reported.
Additional Manufacturer Narrative
A system service check of the medrad® stellant flex injection system, serial number (b)(6), was performed on (b)(6) 2024, 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 has been accepted by the customer and will be scheduled.The medrad® stellant flex 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.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 system service check of the medrad® stellant flex ct injection system, serial number (b)(6), was performed on (b)(6) 2024, which confirmed that the injector was operating within bayer specifications.The disposable kit that was in use during the procedure was discarded by the site; however, the site provided a lot number of the subject disposable.Bayer product analysis tested a retained sample from disposable flexd-150-scs kit, lot number 8643936.Functional testing concluded that the retained disposables performed to specification with no problems observed.Additional clinical applications training was completed and provided by the bayer clinical performance center.The medrad® stellant flex 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.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 inc.Was informed that an 87-year-old female undergoing a ct scan of the chest suffered an alleged air injection while connected to a medrad® stellant flex ct injection system (sn (b)(6)).After receiving an undisclosed amount of air, the patient complained of shortness of breath with decreasing oxygen saturation.Supplemental oxygen was administered, and the patient was transferred to the emergency department for further care.The patient was subsequently discharged and was reported to be doing well with no further issues reported.Note: bayer medical care inc.Received a medwatch (mw5158297) for this issue on september 3, 2024.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: jason johnson ; 1 bayer drive; indianola, PA 15051 ; 4124063016
• MDR Report Key: 19681041
• Report Number: 2520313-2024-00013
• Device Sequence Number: 15162432
• Product Code: DXT
• UDI-Device Identifier: 00616258011219
• UDI-Public: (01)00616258011219
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 85577026
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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-SCS, LOT NUMBER 8643936
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native