FDA Adverse Event
Malfunction
Summary report: N
EMPOWER CT INJECTOR SYSTEM
MDR report key: 485352
·
Received September 19, 2003
Report
- Report Number
- 2411512-2003-00011
- Event Type
- Malfunction
- Date Received
- September 19, 2003
- Date of Event
- July 1, 2003
- Report Date
- August 19, 2003
- Manufacturer
- E-Z-EM, INC.
- Product Code
- JAK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN EXTRAVASATION INCIDENT THAT WAS NOT DETECTED BY THE EDA PATCH. THE TOTAL VOLUME OF CONTRAST TO BE INJECTED WAS 60 ML AT A FLOW RATE OF 3.0 CC/SEC. IT WAS ESTIMATED THAT APPROXIMATELY 40 ML OF CONTRAST EXTRAVASATED INTO THE PT. THE PT WAS INSTRUCTED TO USE WARM COMPRESSES UNTIL THE SWELLING WENT AWAY. IF THERE WAS A PROBLEM, THE PT WAS TO REPORT IT TO THE PHYSICIAN AND NOTHING WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EMPOWER CT INJECTOR SYSTEM | CT INJECTOR SYSTEM WITH EDA | JAK | E-Z-EM, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other | ULTRAVIST 300 NON-IONIC CONTRAST,| JELCO STRIPE 20GA CATHETER. |