FDA Adverse Event Injury Summary report: N

INJECTOR, OPTIVANTAGE DH

MDR report key: 2051137 · Received April 5, 2011

Report

Report Number: 1518293-2011-00061
Event Type: Injury
Date Received: April 5, 2011
Date of Event: March 11, 2011
Report Date: March 14, 2011
Manufacturer: LIEBEL-FLARSHEIM CO.
Product Code: IZQ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND VERIFIED PROPER OPERATION PER THE SERVICE MANUAL (B)(4). ALL INJECTOR FUNCTIONS AND CALIBRATIONS WERE WITHIN THE MANUFACTURER SPECIFICATIONS. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

Description of Event or Problem · 1

ON (B)(6): TECHNOLOGIST REPORTED ON (B)(6) 2011 AT 3:45 PM, HE BEGAN DRAWING CONTRAST FOR A CT/CARDIAC EXAM ON A (B)(6) MALE PATIENT DUE TO SHORTNESS OF BREATH. THE CHIEF TECH WAS IN THE ROOM TO MONITOR PATIENT AND PROCESS. PATIENT WAS ADMINISTERED 90CC OF OPTIRAY 350. DURING THE PROCEDURE, A VERY SMALL AMOUNT OF AIR WAS NOTICED AT THE TOP OF THE PULMONARY ARTERY. THE PATIENT DID NOT EXPERIENCE ANY PROBLEMS. THEREFORE, NO TREATMENT WAS NECESSARY. PATIENT WAS OBSERVED 20-30 MINUTES AND DISCHARGED. LINES WERE PURGED TO INTERSECTION FOR CONTRAST AND SALINE PURGED IN TUBING. NO AIR WAS SEEN BY TECHNOLOGIST PRIOR TO INJECTION. TECHNOLOGIST FLIPPED SYRINGE, ATTACHED ALLIGATOR CLIP AND PROCEEDED WITH SCAN. CONTRAST: 120CC OF OPTIRAY 350 IN 1ST SYRINGE, 60CC SALINE IN 2ND SYRINGE. IV ACCESS SITE: LEFT AC, IV ACCESS DEVICE: 20GA BD AUTO QUART. INJECTION PROTOCOL: 5CC/SECOND 90CC CONTRAST, 7CC/SECOND FOR 40CC FLUSH SALINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INJECTOR, OPTIVANTAGE DH	CT POWER INJECTOR SYSTEM	IZQ	LIEBEL-FLARSHEIM CO.	OPTIVANTAGE DH	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR