• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIEBEL-FLARSHEIM INJ. OPTIV DH,SI W/OEM Back to Search Results
Model Number 844005
Device Problem Pressure Problem (3012)
Patient Problems Infiltration into Tissue (1931); Pain (1994)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary: incident: a customer contacted guerbet technical support stating that, while using their optivantage injector, their first two patients felt pain at the injection site, while the third patient experienced an apparent infiltration. The customer stated that during the injections, injector pressure seemed very high in each of these consecutive cases, and may have contributed to the infiltration. Guerbet's product monitoring team issued complaint#: (b)(4) for the 2 patients experiencing pain, and complaint#: (b)(4) for the patient experiencing the infiltration. Guerbet sent their regional service representative to the customer's facility to investigate this incident and inspect their injector. During this visit, regional service determined the injector to be fully functional and performing to specifications per test and inspection data checklist (846130). Working with the customer's nurse, regional service could not duplicated the issue or verify the complaint. Although the injector is not capable of detecting a infiltration, it is equipped with a customer selectable pressure limit feature. Since infiltrations, as well as, injection pressures are primarily the result of customer selected tubing, needle, needle placement, patient position, type of media, as well as, media temperature; guerbet sent their applications specialist to the account to evaluate their procedures and educate their staff to reduce patient risk. During this visit, guerbet's applications specialist explained how different tubing sets can impact flow and injection pressures, as he believed the reported higher pressures and popping sounds were due to the customer's use of an incorrect tubing set attached to the injector. Instead of using the optivantage tubing sets, the customer used lower-pressure optistar injector tubing sets, which restrict flow, increasing pressure. In addition to assisting the customer in ordering the correct disposable tubing set for the injector, the applications specialist retrained hospital staff on the safety rules and precautions contained in the instructions for use. Topics covered included patency checks to prevent infiltrations and extravasation, syringe and tubing set purging to prevent air injections, as well as pressure limit settings to prevent user related issues. A review of guerbet's complaint tracking system indicated the previous complaint to (b)(4) pertained to 'pressure limit issues'. In this case the injector was verified to be operating to specifications, and an applications specialist was sent to the facility to provide additional training. Root / probable cause code: personnel - training - inadequate. Root / probable cause 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: the injector was returned to use. Service could not duplicate issue, but verified that the injector was fully functional and operating according to specifications.
 
Event Description
This incident was reported by a facility in (b)(6) on (b)(6) 2020. A customer contacted guerbet technical support stating that, while using their optivantage injector, their first two patients felt pain at the injection site, while the third patient experienced an apparent infiltration. The customer stated that during the injections, injector pressure seemed very high in each of these consecutive cases, and may have contributed to the infiltration. This case highlights the complaint regarding the two patients who experienced pain at the injection site.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10869076
MDR Text Key219375511
Report Number1518293-2020-00031
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,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 10/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2020
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 Received10/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-