FDA Adverse Event
Malfunction
Summary report: N
EMPOWER CT INJECTOR SYSTEM
MDR report key: 485338
·
Received September 19, 2003
Report
- Report Number
- 2411512-2003-00010
- 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
CUSTOMER REPORTED AN EXTRAVASATION INCIDENT THAT WAS NOT DETECTED BY THE EDA PATCH. THE TOTAL VOLUME OF CONTRAST TO BE INJECTED WAS 140 ML AT A FLOW RATE OF 4.5 CC/SEC. IT WAS ESTIMATED THAT APPROXIMATELY 60 ML OF THE CONTRAST EXTRAVASATED INTO THE PT. THE PT WAS INSTRUCTED TO USE WARM COMPRESSES UNTIL THE SWELLING WENT DOWN, AND KEEP THE ARM ELEVATED FOR TWO DAYS. IF THERE WAS A PROBLEM, THE PT WAS TO REPORT IT TO THEIR 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. |