FDA Adverse Event
Malfunction
Summary report: N
PERCUPUMP CT INJECTOR W/EDA
MDR report key: 296720
·
Received September 14, 2000
Report
- Report Number
- 2432460-2000-00028
- Event Type
- Malfunction
- Date Received
- September 14, 2000
- Date of Event
- August 22, 2000
- Report Date
- August 22, 2000
- Manufacturer
- E-Z-EM, INC.
- Product Code
- FIH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
UNIT WAS SET TO INJECT A TOTAL VOLUME OF 100 ML OF CONTRAST AT A FLOW RATE OF 2.5 CC/SEC. ACCORDING TO FACILITY, THE SYSTEM FAILED TO DETECT AN EXTRAVASATION, ESTIMATED TO BE APPROX 90 CC'S.
Description of Event or Problem · 1
SYSTEM MISSED AN EXTRAVASATION OF 90 CC'S THAT THE EDCA PATCH DID NOT PICK UP. SYSTEM BEGAN TO READ "EDA INOPERABLE."
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 | UNKNOWN | Other | TYPE OF CATHETER IS UNK.| OMNIPAQUE 350 NON-IONIC CONTRAST MFG BY NYCOMED, |