MAUDE Adverse Event Report: BRACCO INJENEERING S. A. CARDIOGEN 82 INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 12/15/2018

Event Type  malfunction  

Event Description

The reporter, a pharmacist, states that 8 different pts received higher doses than intended due to a malfunction of the cardiogen 82 device on three separate days. On (b)(6) 2018, (2 pts), (b)(6) 2018 (2 pts), and (b)(6) 2018 (4 pts).

• Brand Name: CARDIOGEN 82
• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BRACCO INJENEERING S. A.
• MDR Report Key: 8248386
• MDR Text Key: 133484063
• Report Number: MW5083078
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 01/11/2019 Patient Sequence Number: 1