FDA Adverse Event
Malfunction
Summary report: N
PERCUPUMP CT INJECTOR W/EDA
MDR report key: 282572
·
Received June 14, 2000
Report
- Report Number
- 2432460-2000-00021
- Event Type
- Malfunction
- Date Received
- June 14, 2000
- Date of Event
- May 11, 2000
- Report Date
- May 15, 2000
- Manufacturer
- E-Z-EM, INC.
- Product Code
- FIH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS RPEORTED THAT THE INJECTOR FLOW RATE WAS SET FOR 2.0CC/SEC. AND THE INJECTION SITE WAS THE LEFT ANTECUBITAL FOSSA. AFTER INJECTING THE TOTAL CONTRAST VOLUME (107 ML), NO ENHANCEMENT WAS NOTICED ON THE FILMS. THE PT WAS CHECKED AND SIGNIFICANT SWELLING HAD OCCURRED UNDER THE AREA OF THE EDA PATCH. THE PT WAS TREATED WITH COLD COMPRESSES AND REFERRED TO A PLASTIC SURGEON FOR CONSULTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCUPUMP CT INJECTOR W/EDA | CT INJECTOR WITH EXTRAVASATION ACCESSORY | FIH | E-Z-EM, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other | CONTRAST, 3. LUER LOCK NEEDLE FREE VALVE.| 1. 20 GAUGE ANGIOCATH, 2. OMNIPAQUE 300 NON-IONIC |