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

Catalog Number	017376
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an mri using the empowermr injection system to administer contrast media, a patient experienced an extravasation of contrast media in the forearm, with pain and edema in the local site of the injection.The patient was immediately treated with an ice compress.The patient reported improvement on (b)(6) 2025.
Additional Manufacturer Narrative
The empowermr injection system, serial number (b)(6) has been requested to be returned for evaluation.The consumables used during the case were discarded by the user facility and the lot numbers are unknown.The information provided by the user facility will be reviewed by bracco's medical advisor and the clinical assessment along with the investigation results provided in a follow-up report.
Additional Manufacturer Narrative
The empowermr injector system serial number (b)(6) was not returned for investigation.There was no indication of a device malfunction based on the available information.The cause of this event is unknown; however, the nature of the report and customer history is suggestive of use error.There was no report of any serious injury to the patient in association with this event.Per the empowermr injector user's guide, administering intravenous contrast or saline with an injection poses the risk of extravasation.As with any procedure that involves intravenous injection of a substance, proper technique can substantially reduce the incidence of extravasation.While the attending physician must always establish the specific technique, suggested precautions when using the empowermr injector system are included in the empowermr injector user's guide for minimizing extravasations.The information provided by the user facility was reviewed by bracco's medical advisor and this clinical assessment is as follows: no patient information (age, weight, gender, medical history or type or reason for the scan) was provided.Venous access was gained in the usual manner.The scan was initiated without incident using an unreported amount of prohance contrast media.The patient experienced an extravasation of contrast media with pain and edema at the site of injection.The patient was immediately treated with ice compress and released to home.Follow up three days later confirmed significant improvement.No other interventions were required.It is somewhat difficult to assess the risk to this patient given the paucity of information provided although it can be assumed that the patient was given a standard dose of magnetic resonance (mr) contrast media (20 ml) and that 75% (15 ml) of the contrast media extravasated.This volume of a physiologically biocompatible fluid would pose minimal risk of harm to the patient.This report is closed.

• Brand Name: EMPOWERMR
• Common Device Name: CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY
• Manufacturer (Section D): BRACCO INJENEERING S.A.; avenue de sévelin 46; lausanne 1004; SZ
• 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 ; 9529959300
• MDR Report Key: 22560872
• Report Number: 3004753774-2025-00004
• Device Sequence Number: 18509982
• Product Code: IZQ
• UDI-Device Identifier: 47630039300973
• UDI-Public: 47630039300973
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K062449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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 Catalogue Number: 017376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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: BRACCO PROHANCE CONTRAST MEDIA, LOT# 4E84346.; GABMED DOUBLE TRANSFER, LOT# 24K44.; GABMED PATIENT SET KIT, LOT# 25B45.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 78 KG