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U.S. Department of Health and Human Services

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

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LIEBEL-FLARSHEIM INJ. OPTIV DH,SI W/OEM Back to Search Results
Model Number 844005
Device Problem Use of Device Problem (1670)
Patient Problem Pulmonary Embolism (1498)
Event Date 11/13/2020
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary incident: after an injection with the optivantage, the patient was seen to have air in the pulmonary arch. The tech states she verified all air was expelled from the syringe and tubing prior to connecting the tubing to the patient. Investigation: a guerbet senior application specialist went onsite and retrained the technologists on the fill/purge sequence and really stressed making sure the injector was in a vertical or upright position for filling syringes and purging the air from the tubing. The app's specialist said the tech who injected the air stated they must have done something wrong in the fill/purge and took responsibility for the incident. A guerbet service call was not requested at this time. The injector does not have the capability to prevent or detect an extravasation (infiltration). However, precautions to minimize an extravasation are provided in the operator's manual. Additionally, described in the manual are i. V. Site patency check techniques, including a manual method and another using a patency key in the setup screen. Cts history search shows no other similar issues with this unit. Root / probable cause code personnel - performance - failed to follow procedure root / probable cause summary 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. Disposition summary a guerbet senior application specialist went onsite and retrained the technologists on the fill/purge sequence and really stressed making sure the injector was in a vertical or upright position for filling syringes and purging the air from the tubing.
 
Event Description
This incident was reported by a facility in (b)(6) 2020. A customer stated that after an injection with the optivantage, the patient was seen to have air in the pulmonary arch. The tech states she verified all air was expelled from the syringe and tubing prior to connecting the tubing to the patient. She preformed a routine ct of the chest with a flow rate of 2ml/sec for a total of 75ml's of contrast. The contrast used was omnipaque. She was later notified by the radiologist that there was a small amount of air in the pulmonary arch. The patient was released immediately after the ct and a follow up phone call was made after speaking with the radiologist.
 
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Brand NameINJ. OPTIV DH,SI W/OEM
Type of DeviceINJ. 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 Key10978315
MDR Text Key221265060
Report Number1518293-2020-00040
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 company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 11/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844005
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 Received11/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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