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

Model Number	85631829
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A bayer clinical compliance lead spoke to the customer who reported that this incident occurred due to a user error.Ct in contravention of explicit warnings/instructions from the stellant ct injection system operation manual, a student failed to prime the low-pressure connector tubing (lpct) prior to connecting to the patient.The customer took full responsibility for the alleged incident and confirmed that this incident was not due to a fault of the stellant injector and/or disposables.Consequently, they subsequently declined an injector check by bayer service.The site continues to use the injector after the reported event with no further issues reported.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 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 and underwent a chest-ray and lower extremity ultrasound for precaution/observation.The customer reported that they have not received any further information from the patient.

• Brand Name: STELLAT DUAL CT INJECTOR STELLAT DUAL CT INJECTOR STELLAT DUAL CT INJECTOR STELL
• 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: 16820134
• Report Number: 2520313-2023-00008
• Device Sequence Number: 15227817
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/26/2023

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2011
• 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: FLEX-150-SPK, LOT NUMBER 8623663.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown