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U.S. Department of Health and Human Services

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

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LIEBEL-FLARSHEIM INJECTOR, OPTIVANTAGE DH W/RFID Back to Search Results
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. ".
 
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Brand NameINJECTOR, OPTIVANTAGE DH W/RFID
Type of DeviceINJECTOR, 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 Key6442228
MDR Text Key71478165
Report Number1518293-2017-00010
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063503
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number844003
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/30/2010
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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