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

Model Number 844005

Device Problem Increase in Pressure (1491)

Patient Problems Infiltration into Tissue (1931); Pain (1994)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: incident: a customer contacted guerbet technical support stating that, while using their optivantage injector, their first two patients felt pain at the injection site, while the third patient experienced an apparent infiltration.The customer stated that during the injections, injector pressure seemed very high in each of these consecutive cases, and may have contributed to the infiltration.Guerbet's product monitoring team issued complaint (b)(4) for the 2 patients experiencing pain, and complaint (b)(4) for the patient experiencing the infiltration.Guerbet sent their regional service representative to the customer's facility to investigate this incident and inspect their injector.During this visit, regional service determined the injector to be fully functional and performing to specifications per test and inspection data checklist (846130).Working with the customer's nurse, regional service could not duplicated the issue or verify the complaint.Although the injector is not capable of detecting a infiltration, it is equipped with a customer selectable pressure limit feature.Since infiltrations, as well as, injection pressures are primarily the result of customer selected tubing, needle, needle placement, patient position, type of media, as well as, media temperature; guerbet sent their applications specialist to the account to evaluate their procedures and educate their staff to reduce patient risk.During this visit, guerbet's applications specialist explained how different tubing sets can impact flow and injection pressures, as he believed the reported higher pressures and popping sounds were due to the customer's use of an incorrect tubing set attached to the injector.Instead of using the optivantage tubing sets, the customer used lower-pressure optistar injector tubing sets, which restrict flow, increasing pressure.In addition to assisting the customer in ordering the correct disposable tubing set for the injector, the applications specialist retrained hospital staff on the safety rules and precautions contained in the instructions for use.Topics covered included patency checks to prevent infiltrations and extravasation, syringe and tubing set purging to prevent air injections, as well as pressure limit settings to prevent user related issues.A review of guerbet's complaint tracking system indicated the previous complaint to mk202010-0072 & mk202010-0142 pertained to 'pressure limit issues'.In this case the injector was verified to be operating to specifications, and an applications specialist was sent to the facility to provide additional training.Root / probable cause code: personnel - training - inadequate 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: the injector was returned to use.Service could not duplicate issue, but verified that the injector was fully functional and operating according to specifications.

Event Description

This incident was reported by a facility in (b)(6) 2020.A customer contacted guerbet technical support stating that, while using their optivantage injector, their first two patients felt pain at the injection site, while the third patient experienced an apparent infiltration.The customer stated that during the injections, injector pressure seemed very high in each of these consecutive cases, and may have contributed to the infiltration.This case highlights the complaint regarding the patient who experienced the infiltration.

• 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: 10869075
• MDR Text Key: 218255304
• Report Number: 1518293-2020-00032
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1