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

Model Number 844005

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary incident: a patient was scanned for a routine chest abdomen pelvis ct.(tech was) notified after by the radiologist that he saw a small amount of air in the pulmonary arch.The tech states she followed the load, purge and enable sequence properly and all air should have been purged from the injector.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 we tried to duplicate the air in the syringe by loading at different angles but could not pinpoint 1 thing they did wrong.They realized it had to be tech error as they are ultimately responsible to check the syringe & tubing for any air.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 air injection' issues with this unit.Note: search did show a newer complaint initiated days after this complaint for "needs to be recalibrated in the tilt".This was completed by guerbet service and the unit operation was verified.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) on (b)(6) 2020.A patient was scanned this morning for a routine chest abdomen pelvis ct as a follow up to colon ca.The tech loaded the injector with 100ml's of omnipaque, she then bled the line, tilted the injector down and attached it to the patient.She injected at a flow rate of 2.5ml/sec for the total 100ml's of contrast.Upon completion of the exam, she released the patient.She was notified after by the radiologist that he saw a small amount of air in the pulmonary arch.The tech states she followed the load, purge and enable sequence properly and all air should have been purged from the injector.Patient attached.

• 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: 10978306
• MDR Text Key: 245336602
• Report Number: 1518293-2020-00042
• 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

• Date FDA Received: 12/09/2020
• 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
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1