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

Model Number 844007

Device Problems Filling Problem (1233); Defective Device (2588)

Patient Problems Respiratory Distress (2045); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 08/20/2018

Event Type  malfunction  

Event Description

Initial notification on (b)(6) 2018, reporter states that intermittently, when putting on syringes user can not see if air is present, potential air injection, patient attached and felt ill after injection.Report receiver spoke with ct technologist, and she said they have difficulty making sure that all of the air is purged out of the syringe and y-tubing.She asked if lf has a clear, non-opaque, syringe available.Report receiver explained that we do not.She was not asserting that the injector malfunctioned and caused air to be injected, rather she said that the fact that the 200 ml syringes are opaque and not clear contributed to a possible air injection.They have decided not to use the injector until an fse comes and looks at the system.They would also like applications to give them a call.In regards to patient injury, reporter states that tech hooked up contrast and saline syringes, hit auto fill, went to scanner, the injector said it was filled.Tech cannot see if its filled.Tech hit purge.Looked like contrast came in, saline came in.Looked as if it was working, hooked up to patient.Patient got warm assumed she got contrast, but then air came through because patient go a lot of air? patient started coughing and said felt ill.Injector said there was 100 cc's in there was air on the scan.Everything seemed as if it was working ok, but tech states clearly was not.Follow-up with reporter on (b)(6) 2018, reporter states that the contrast and saline used during this procedure was omnipaque 300 and an unnamed non-guerbet 0.9% sodium chloride.

Event Description

This is a supplemental report to the original report (b)(4), manufacturer report number 1518293-2018-00033, submitted to the fda on 18 september 2018, highlighting the company assessment.

Manufacturer Narrative

Overall investigation summary is as follows: incident: user can't tell if air or contrast is being sucked up.They are using manual fill syringes (844022, optivantage syringe dual pack w/ coiled y tubing).Request to check for proper operation.Regional service was unable to find any issues with the injector and verified operation according to test and inspection data checklist (846130).The injector was fully functional.Ok to use.Guerbet applications also visited site and a summary of their discussion with the customer is in the attachments.Is a possible use issue associated with properly purging air from tubing and/or syringes.Also, users were new to injector and were used to using syringes that were clear vs opaque.Cts history search shows no other similar issues with this unit.Root/probable cause code is as follows: personnel - performance - failed to follow procedure - probable root cause was operator error in purging air from syringe and/or tubing (ref.Ifu, (b)(4), section 4.1).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.Dispostion summary is as follows: service was unable to find any issues with the injector and verified operation.The injector was fully functional.Ok to use.

• Brand Name: INJ. OPTIV DH, W/OEM
• Type of Device: INJ. OPTIV DH, W/OEM
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati OH 45237
• MDR Report Key: 7885010
• MDR Text Key: 121461408
• Report Number: 1518293-2018-00033
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 844007
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1