MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. STELLAT 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	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the stellant flex ct injector, serial number (b)(4), was completed on (b)(6) 2021 which confirmed that the injector was operating within bayer specifications.The disposables that were in use during the alleged incident were discarded by the site.The lot number was not provided; therefore, testing of retained samples was not possible.The additional applications training has been scheduled for (b)(6) 2021.The site continues to use the stellant ct injection system after the reported event with no further issues reported.In the event that additional information is obtained, 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
The customer reported the following: an outpatient underwent a ct scan of the abdomen and pelvis with contrast while connected to a stellant flex ct injection system.Following the injection, an undisclosed amount of air was visualized on the subsequent images.The exact anatomical location of the alleged air was not disclosed.Although the patient was asymptomatic throughout the examination, the radiologist ordered a ct scan of the chest to evaluate for air after which the patient was transferred to the emergency department for further evaluation.The current status of the patient is unknown.

• Brand Name: STELLAT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 12471092
• Report Number: 2520313-2021-00034
• Device Sequence Number: 11707105
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other