FDA Adverse Event
Injury
Summary report: N
OPTIVANTAGE WITH PEDESTAL
MDR report key: 2130486
·
Received June 14, 2011
Report
- Report Number
- 1518293-2011-00101
- Event Type
- Injury
- Date Received
- June 14, 2011
- Report Date
- May 20, 2011
- Manufacturer
- LIEBEL-FLARSHEIM CO
- Product Code
- IZQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CUSTOMER REPORTS A FEMALE PATIENT HAVING A CT SCAN OF THE CORONARY ARTERY WITH CONTRAST. GREEN CANNULA INSERTED FOR IV ACCESS. OPTIRAY 350 PREFILLED SYRINGE LOADED INTO THE INJECTOR. STAFF NOTED THE PRESENCE OF AIR WITHIN THE PULMONARY ARTERY. THE ATTENDING RADIOLOGY REGISTRAR WAS IMMEDIATELY INFORMED AND HE EXAMINED THE PATIENT. SHE WAS SYMPTOMATIC, AND WAS INFORMED OF THE PRESENCE OF THE AIR, ADVISED TO CONTACT HOSPITAL IF SYMPTOMS DEVELOP. PATIENT OBSERVED AND ALLOWED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIVANTAGE WITH PEDESTAL | CT POWER INJECTOR SYSTEM | IZQ | LIEBEL-FLARSHEIM CO | OPTIVANTAGE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |