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

Model Number	85631829
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® stellant flex ct injection system, serial number (b)(6), was completed on august 7, 2023 which confirmed that the injector was operating within bayer specifications.The disposables in use at the time of the incident were discarded, and the lot number was not provided; therefore, testing of retained samples is not possible.The offer of additional applications training was declined by the customer.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 received information that a 93-year-old female patient who underwent a ct of the abdomen and pelvis with iv contrast for left lower quadrant abdominal pain and diarrhea suffered an air injection while connected to a medrad® stellant flex ct injection system (sn (b)(6)).The customer reported that approximately 140 ml of air was observed on the displayed images.Following the injection, the patient went into cardiac arrest, after which undisclosed medical intervention was performed.The customer reported that the patient had been discharged with no further issues reported.Bayer medical care received information that a 93-year-old female patient who underwent a ct of the abdomen and pelvis with iv contrast for left lower quadrant abdominal pain and diarrhea suffered an air injection while connected to a medrad® stellant flex ct injection system (sn (b)(6)).The customer reported that approximately 140 ml of air was observed on the displayed images.Following the injection, the patient went into cardiac arrest, after which undisclosed medical intervention was performed.The customer reported that the patient had been discharged with no further issues reported.

• 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: jason johnson ; one bayer drive; indianola, PA 15051 ; 4124063016
• MDR Report Key: 17653552
• Report Number: 2520313-2023-00020
• Device Sequence Number: 17720548
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/30/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 34 KG