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

Model Number 844005

Device Problems Inaccurate Delivery (2339); Activation, Positioning or SeparationProblem (2906); Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

This incident was reported by a facility in utrecht, netherlands on (b)(6) 2021. The reporter states that after upgrading 2 optivantages error code 2048 (miscellaneous software alarm) is coming up several times. After starting the injector up it goes well for some time and then comes up again. The last time the injector failed during an injection. Reporter states that during the injection of the contrast the injector stopped. At that moment patient had not received enough contrast to make a good picture, therefore, they did not start the scanning. Facility restarted the injector, and then inject another doses of contrast, at the end the patient did become 50cc contrast more than was planned. Reporter states that the kidney function of this patient is ok, not a problem for this patient, and that the procedure completed.

Manufacturer Narrative

Overall investigation summary incident: after upgrading 2 optivantages error code 2048 (miscellaneous software alarm) was coming up several times. During the injection of the contrast this injector stopped. They restarted the injector. Procedure completed. Regional service gave loan injectors to the customer(s). Service reported: "the factory (technician) did not find a cause of error 2048, therefore they removed the oem interface pcb's (b)(4), as this solved the problem in previous cases. " the customer units are currently in the workshop as the loaner units are in use. Cts history search shows no other similar issues with this unit. Impact assessment summary (b)(4). Equipment/instrument software 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. "the factory (technician) did not find a cause of error 2048, therefore they removed the oem interface pcb's (b)(4), as this solved the problem in previous cases. " the customer units are currently in the workshop as the loaner units are in use.

• 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: 12909693
• MDR Text Key: 283779770
• Report Number: 1518293-2021-00039
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 844005
• Device Lot Number: CI0512B556
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2012
• Is This a Reprocessed and Reused Single-Use Device?: No