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U.S. Department of Health and Human Services

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

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BRACCO INJENEERING S. A. CARDIOGEN 82 INJECTOR, CONTRAST MEDIUM, AUTOMATIC Back to Search Results
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).
 
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Brand NameCARDIOGEN 82
Type of DeviceINJECTOR, CONTRAST MEDIUM, AUTOMATIC
Manufacturer (Section D)
BRACCO INJENEERING S. A.
MDR Report Key8248386
MDR Text Key133484063
Report NumberMW5083078
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/11/2019
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
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