FDA Adverse Event
Injury
Summary report: N
OPTIVANTAGE DH
MDR report key: 1000211
·
Received February 19, 2008
Report
- Report Number
- 1518293-2008-00019
- Event Type
- Injury
- Date Received
- February 19, 2008
- Date of Event
- January 15, 2008
- Report Date
- January 23, 2008
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- IZQ
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LIEBEL FLARSHEIM SERVICE REPORT FIELD SERVICE ENGINEER COMPLETED OPTIVANTAGE MAINTENANCE CHECK LIST INCLUDING FLOW RATE AND PRESSURE LIMITS CHECKS PER CHAPTER 4 OF THE OPTIVANTAGE SERVICE MANUAL.
Description of Event or Problem · 1
CUSTOMER REPORTED IN 2008, THAT A MALE WITH HISTORY OF AAA AND A NECK MASS WAS UNDERGOING A CT OF THE ABDOMEN/PELVIS AND NECK WITH CONTRAST (VISIPAQUE) TO RULE OUT AN ANEURYSM. CUSTOMER NOTICED AN INFILTRATION AT THE LEFT ANTECUBITAL WHERE AN ANGIOCATH WAS INSERTED FOR IV ACCESS. A COOL COMPRESS WAS APPLIED TO STABILIZE THE INFILTRATION FOR 15 MINUTES. THE CUSTOMER WAS RELEASED. THE PROTOCOLS USED FOR THE PROCEDURE WERE 4ML/SEC FOR A TOTAL VOLUME OF 125ML AND A PSI OF 325.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIVANTAGE DH | NONE | IZQ | LIEBEL-FLARSHEIM CO. | OPTIVANTAGE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |