MAUDE Adverse Event Report: LIEBEL-FLARSHEIM INJECTOR, OPTIVANTAGE DH W/RFID

Model Number 844003

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2017

Event Type  malfunction  

Event Description

Changing flow rate: the customer is also indicating that it was reported that the flow rate was changed on the control before or during the injection for 1.5 ml/sec to 4 ml/sec.I instructed the customer to further verify this report.The customer indicated this is what was perceived by the operator of the device that the input flow rate somehow changed during the injection.The customer indicated there is an internal investigation at the hospital to determine what occurred."patient's iv was flushed with 10 cc of saline manually to test iv.The iv was working sufficiently.Contrast then inject through ct contrast injector, injector was set at 1.8 cc/sec but equipment malfunctioned and changed to 4 cc/sec.Approx.50 cc contrast infiltrated.Both the er nurse (xxx) and radiologist (dr.Yyyyy) were notified.The iv was removed and an ice pack was applied.The extremity was elevated per department protocol.".

• Brand Name: INJECTOR, OPTIVANTAGE DH W/RFID
• Type of Device: INJECTOR, OPTIVANTAGE DH W/RFID
• 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: 6442228
• MDR Text Key: 71478165
• Report Number: 1518293-2017-00010
• 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
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 844003
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Date Device Manufactured: 09/30/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1