MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJ. OPTIV DH,SI W/OEM

Model Number 844005

Device Problem Use of Device Problem (1670)

Patient Problem Pulmonary Embolism (1498)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary incident: after an injection with the optivantage, the patient was seen to have air in the pulmonary arch.The tech states she verified all air was expelled from the syringe and tubing prior to connecting the tubing to the patient.Investigation: a guerbet senior application specialist went onsite and retrained the technologists on the fill/purge sequence and really stressed making sure the injector was in a vertical or upright position for filling syringes and purging the air from the tubing.The app's specialist said the tech who injected the air stated they must have done something wrong in the fill/purge and took responsibility for the incident.A guerbet service call was not requested at this time.The injector does not have the capability to prevent or detect an extravasation (infiltration).However, precautions to minimize an extravasation are provided in the operator's manual.Additionally, described in the manual are i.V.Site patency check techniques, including a manual method and another using a patency key in the setup screen.Cts history search shows no other similar issues with this unit.Root / probable cause code personnel - performance - failed to follow procedure root / probable cause summary see failure mode (see components and overall investigation summary).No further investigation needed at this time.Qa will continue to monitor and trend for similar issues.No capa at this time, these trends and issues are reported on during quality metrics reviews and during the management review meetings to consider input for corrective action.Disposition summary a guerbet senior application specialist went onsite and retrained the technologists on the fill/purge sequence and really stressed making sure the injector was in a vertical or upright position for filling syringes and purging the air from the tubing.

Event Description

This incident was reported by a facility in (b)(6) 2020.A customer stated that after an injection with the optivantage, the patient was seen to have air in the pulmonary arch.The tech states she verified all air was expelled from the syringe and tubing prior to connecting the tubing to the patient.She preformed a routine ct of the chest with a flow rate of 2ml/sec for a total of 75ml's of contrast.The contrast used was omnipaque.She was later notified by the radiologist that there was a small amount of air in the pulmonary arch.The patient was released immediately after the ct and a follow up phone call was made after speaking with the radiologist.

• Brand Name: INJ. OPTIV DH,SI W/OEM
• Type of Device: INJ. OPTIV DH,SI W/OEM
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 10978315
• MDR Text Key: 221265060
• Report Number: 1518293-2020-00040
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 844005
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1