MAUDE Adverse Event Report: BRACCO INJENEERING SA EMPOWERCTA+; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Model Number EMPOWERCTA+

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 11/11/2023

Event Type  Injury  

Event Description

On (b)(6), 2023, (b)(4) became aware that after a computed tomography (ct) scan of the abdomen and pelvis with an empowercta+ injection system, serial number (b)(6), the technologist noticed an unknown amount of isovue 300 contrast on the floor from a leaking connection between the injector tubing and the intravenous (iv) line.An unknown amount of air was later observed in the imaging in the patient's left ventricle.On (b)(6) 2023, (b)(4) became aware the patient was transferred to another hospital due to the visualization of air on the ct images.The patient was reported to have recovered on (b)(6) 2023.

Manufacturer Narrative

H3: on november 12, 2023, testing was performed on the empowercta+ injector, system serial number (b)(6) by a bracco service technician.The injection system was functionally tested and met the pre-established specifications.The consumable kits used during the event were not available for evaluation; the consumable kits had been discarded by the user facility.Also, lot information for the consumable kits used during the event were not provided so no further investigation can be conducted on the consumable kits.A device history record review will be completed for the empowercta+ injector system, serial number (b)(6).A review of the copies of the ct scans provided by the user facility will be completed by bracco's medical advisory board member.Upon completion of the device history record reviews and review of the ct scans, a follow-up report will be submitted to the fda.

Manufacturer Narrative

H3: a review of the device history records for empowercta+ injector, system serial number (b)(6), was completed on 28 december 2023.There was no evidence of a quality issue or device malfunction related to the reported event based on the device history record review.Per information provided by the user facility, the cause of the event was most likely due to user error.The ct scans of the patient procedure were provided to acist and reviewed by the acist medical advisory board member.The assessment is as following: the radiographers who carried out the examination did not notice the presence of air at the time of examination.The radiologist who examined the images later called attention to the presence of air.The patient remained asymptomatic during and after the scan but was transferred to a larger and better equipped hospital for observation and follow-up.It is not known if the patient required any medical intervention.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.Based upon examination of the 50 scan images provided, the estimated volume of air is less than 10 cc.Per the empowercta+ user's guide, "the empowercta®+ injector system must be used properly to prevent the risk of an air embolism.Always fill the syringe with the injector pointing fully upward.When the syringe has been filled to the desired volume, all the air should be purged from the syringe and coiled tubing with the injector still in the fully vertical position.Failure to do so may lead to serious injury and/or death." based on acist's investigation, there was no evidence of device malfunction related to this event.

• Brand Name: EMPOWERCTA+
• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BRACCO INJENEERING SA; 46 avenue de sévelin; lausanne,
• Manufacturer (Section G): ACIST MEDICAL SYSTEMS; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: teresa butler ; 7905 fuller road; eden prairie, MN 55344 ; 6125006492
• MDR Report Key: 18414463
• MDR Text Key: 331577210
• Report Number: 3004753774-2023-00005
• Device Sequence Number: 1
• Product Code: IZQ
• UDI-Device Identifier: 47630039300904
• UDI-Public: (01)47630039300904(11)210517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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
• Device Operator: Health Professional
• Device Model Number: EMPOWERCTA+
• Device Catalogue Number: 017285
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ISOVUE 300
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female