MAUDE Adverse Event Report: BRACCO INJENEERING S.A. EMPOWER CTA+

Model Number	017285
Medical Device Problem Codes	Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Distress (2329)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The injector had injected on its own when operator wasn't watching.Patient said her arm was burning.Tech said 70-80ml's was injected.Patient suffered pain and distress.
Additional Manufacturer Narrative
Unable to confirm complaint.Performed set-up procedure, and performed multiple injections, both wet and dry with varying flow rates,pressures and volumes.In all cases, the injection began when prompted(either from the control panel or remote), paused when prompted (control panel, remote, pendant) and complete after the programmed amount of contrast had been delivered.The system was left "armed" for differing lengths of time and observed.There was no indication of "self-injection" in any of the cases.All possible investigations were made on this system but no defect was found.All the subsystems of this injector has been changed as preventive action.
Event or Problem Description
The injector had injected on its own when operator wasn't watching.Patient said her arm was burning.Tech said 70-80ml's was injected.Patient suffered pain and distress.

• Brand Name: EMPOWER CTA+
• Common Device Name: EMPOWER CTA+
• Manufacturer (Section D): BRACCO INJENEERING S.A.; lausanne, ; SZ
• MDR Report Key: 8824007
• Report Number: 3004753774-2019-00003
• Device Sequence Number: 3039646
• Product Code: IZQ
• UDI-Device Identifier: 47630039300430
• UDI-Public: (01)47630039300430
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: 071378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 017285
• Device Catalogue Number: 017285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 77