MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJECTOR, OPTIVANTAGE DH W/RFID

Model Number 844003

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2019

Event Type  malfunction  

Event Description

This incident was reported on (b)(6) 2019, as customer reported that significant amount of air injected into patient while connected to their optivantage dh on (b)(6) 2019.This was a coronary cta procedure utilizing optiray rfid 350 pfs and rfid saline pfs along with guerbet y-connector tubing.Injector was a loaner from a third party called injector service specialists in which we have no service history on.Customer claimed that after purging the system of air and starting the injection she noticed fluid leaking from the proximal saline y-connection area and fluid on floor.During injection the saline connector was tightened to keep from leaking.Patient was unharmed according to imaging director.Administration asked for us to provide training on the injector to the ct staff which we completed on 5/29/2019.

• Brand Name: INJECTOR, OPTIVANTAGE DH W/RFID
• Type of Device: INJECTOR, OPTIVANTAGE DH W/RFID
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, OH 45237
• MDR Report Key: 8744584
• MDR Text Key: 149793411
• Report Number: 1518293-2019-00012
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 844003
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1