FDA Adverse Event
Injury
Summary report: N
OPTIVANTAGE WITH PEDESTAL
MDR report key: 2130424
·
Received June 14, 2011
Report
- Report Number
- 1518293-2011-00100
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- May 19, 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 (B)(6) YEAR OLD PATIENT WAS HAVING A CT CORONARY ARTERY SCAN WITH CONTRAST. GREEN CANNULA INSERTED IN RIGHT ARM AND INJECTOR LOADED WITH OPTIRAY 350 PREFILLED 100ML SYRINGE AND SALINE BOLUS. PATIENT RECEIVED 91ML OF OPTIRAY 350 FOLLOWED BY 42ML OF SODIUM CHLORIDE (SALINE). THE RADIOGRAPHER NOTED ON THE CT SCANS THE PRESENCE OF AIR WITHIN THE VASCULAR SYSTEM. NO CLINICAL SYMPTOMS OCCURRED AND THE PATIENT RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIVANTAGE WITH PEDESTAL | CT POWER INJECTOR SYSTEM | IZQ | LIEBEL-FLARSHEIM CO. | OPTIVANTAGE DH | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |