MAUDE Adverse Event Report: BRACCO INJENEERING S.A. CT EXPRES; CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY

Model Number	3D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)
Date of Event	02/07/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Date of event: the date of awareness of an adverse event was 21 february 2023.The date of awareness of patient death was 28 february 2023.The ct expres 3d injection system, serial number (b)(4), was returned for evaluation on 15 march 2023.The injector system was functionally tested and met the pre-established specifications.A review of the device history was performed with no findings related to the reported event.There was no evidence of device malfunction related to the reported event.The user facility provided to bracco medical technologies (bmt) one (1) computed tomography (ct) image (slice).This single ct slice was reviewed by the bmt medical advisory board (mab) member and the assessment is as follows: it is the opinion of this mab member who is responsible for this device that it has been well established that volumes of air injected intravenously greater than 25 cc have the potential for serious harm, permanent disability, or death; whereas volumes less than 10 cc in adults are considered essentially safe.The radiographers who carried out the examination did not notice the presence of air at that time.The radiologist who examined the images later called attention to the presence of air.Review of the single ct slice provided makes it difficult to estimate the volume of air present.Although volumes > 25 cc have the potential for serious harm, given the patient's health state at the time of admission and the multiple drugs the patient was on as well as the four days that transpired between the scan and the death, air is unlikely to be the cause of death.Although requested, the ct expres consumable kits used during the event are not available for evaluation; these items were discarded by the customer.The lot numbers of the consumables used were not provided or not known.Evaluation of the available information concludes no causal relationship between the ct expres injection system and the reported patient death.
Event or Problem Description
On (b)(6) 2023, the female patient was admitted to the hospital after being found on the floor at home.The patient had been on the floor for three (3) days before being taken to the hospital, and that the patient arrived at the hospital with bruising on her left side.During a computed tomography (ct) chest, abdomen, and pelvis scan using the ct expres 3d injection system, the patient appeared confused and agitated and the patient's blood pressure was less than 90mmhg systolic.The consultant radiologist team reviewing the patient's case observed an air embolus.The patient died on (b)(6) 2023.

• Brand Name: CT EXPRES
• Common Device Name: CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY
• Manufacturer (Section D): BRACCO INJENEERING S.A.; avenue de sévelin 46; lausanne, 1004 ; SZ 1004
• Manufacturer (Section G): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: teresa butler ; 7905 fuller road; eden prairie, MN 55344
• MDR Report Key: 16643672
• Report Number: 3004753774-2023-00003
• Device Sequence Number: 17515677
• Product Code: IZQ
• UDI-Device Identifier: 47630039300096
• UDI-Public: 47630039300096
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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: 3D
• Device Catalogue Number: 650207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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: 20 GAUGE CANNULA; OMNIPAQUE 350 CONTRAST MEDIA
• Outcome Attributed to Adverse Event: Death
• Patient Age: 67 YR
• Patient Sex: Female