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

Model Number 844007

Device Problems Energy Output Problem (1431); Communication or Transmission Problem (2896)

Patient Problem Infiltration into Tissue (1931)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Service statement: "this service request was not sent to an engineer.It has remained in the tech support queue - cits.The customer did not request service at the time, because the error code only happened one time and she wanted to know what it meant or if it could have anything to do with a "possible infiltration" from the previous case, is what she said today" and "i called the customer to verify the information regarding the reported 1008 alarm.We did not find the alarm present in the alarm history.No further information is available regarding that error.I am not sure why it is not appearing in the results history as no other alarms have been reported by their staff since the reported 1008." as of 17 november 2020, the support ticket is closed.

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2020.A customer stated that the optivantage injector was displaying alarm 0x1008 - the console loses communication packets from the powerhead for more than 2 seconds.They stated that this is the only alarm that occurred and has been resolved by cycling the power on the system.This is a ceiling mounted powerhead, and the reporter checked the connections at the back of the power supply, the console, and the powerhead, and has stated that the alarm has not returned after rebooting the system.The reporter stated that this event occurred during a procedure, and that the patient was connected and experienced an infilatraion when the saline portion of the procedure could not be finished due to the alarm.The customer states that the procedure was completed by starting a new iv, and that there was no injury to staff.

• Brand Name: INJ. OPTIV DH, W/OEM
• Type of Device: INJ. OPTIV DH, 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: 10920351
• MDR Text Key: 234409191
• Report Number: 1518293-2020-00037
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 844007
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1