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	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer service performed a system service check of the stellant flex ct injector (sn (b)(4)) on (b)(6) 2023 and determined that the injector was functioning as designed without issue.Analysis of the stellant flex ct system log files found that for the day of the reported incident, there was at least one instance where a logged procedure was performed without priming of the low-pressure connector tubing (lpct), either by manual or automated means.The customer was not able to provide the lot numbers of the disposable kits, which were in use at the time of the reported incident.However, the customer found seven potential sets of flex syringes and attached lpcts in the dedicated disposal bin in the ct room.Product analysis received and examined the seven sets of syringes and attached lpcts.Visual examination found the products to be in good overall condition with no visual defects noted.Functional testing confirmed that the products performed to specification.Additional clinical applications training was provided on (b)(6) 2023.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.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 occurred while a patient was connected to a medrad® stellant flex ct injection system (sn 100176).A 73-year-old male patient was undergoing a ct with contrast, of the abdomen and pelvis for a chief complaint of constipation.Upon completion of the procedure, the patient reported that he "didn't feel well" at which time a rapid response was called.The patient became unresponsive, was intubated, placed on a ventilator, given undisclosed emergency treatment, and subsequently returned to the emergency department for further care.The patient was admitted to the intensive care unit for continued treatment and monitoring.Air was reported to be visualized on the displayed images.The following day, the patient was transferred to another facility to undergo hyperbaric oxygen therapy.The current status of the patient is unknown.

• Brand Name: STELLANT 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: 17558997
• Report Number: 2520313-2023-00019
• Device Sequence Number: 14352593
• Product Code: DXT
• UDI-Device Identifier: 00616258011219
• UDI-Public: (01)00616258011219
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2023

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: 85577026
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 83 KG