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

Model Number 017285

Device Problems Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Pain (1994); Distress (2329)

Event Date 06/19/2019

Event Type  malfunction  

Event 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.

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 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+
• Type of Device: EMPOWER CTA+
• Manufacturer (Section D): BRACCO INJENEERING S.A.; lausanne, ; SZ
• MDR Report Key: 8824007
• MDR Text Key: 152954591
• Report Number: 3004753774-2019-00003
• Device Sequence Number: 1
• Product Code: IZQ
• UDI-Device Identifier: 47630039300430
• UDI-Public: (01)47630039300430
• Combination Product (y/n): N
• PMA/PMN Number: 071378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 017285
• Device Catalogue Number: 017285
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 77