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Model Number 844001
Device Problems Backflow (1064); Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary: incident: a radiographer in korea, contacted guerbet field service stating that while using their optivantage injector with a 125ml optiray prefilled syringe, the injector's ram backs-up slightly after performing the injection. The customer was concerned that perhaps this was an uncontrolled movement and could allow blood to reflux into the tubing. The customer a video of the injector backwards movement. Investigation: the complaint and attached video was reviewed by guerbet's software design, as well as, their technical service manager, who explained that the slight backward motion of the optivantage injector's ram, following an injection, is normal operation and is not a case of uncontrolled movement. This slight backward motion in the video was designed to relieve pressure in the syringe once the injection is concluded. However, this slight backward movement is not enough to cause the amount of blood in the tubing depicted in a photograph in the complaint report attached. Therefore, it was theorized that this situation (blood in tubing) may have been caused by the operator loading a pre-filled syringe having less than 125ml of fluid into the injector, without updating the injector's program. During injection, the injector continued to move the ram forward after all fluid was expelled. Once the fluid was completely expelled, the continued movement of the ram caused a loss of pressure in the syringe, allowing a backward flow of blood into the syringe's tubing, as depicted in the photo. Guerbet's apac technical service team, stated that since the optivantage injector is performing to design specifications, there is no need to service the injector. A review of guerbet's complaint tracking system showed no similar issues with this device. Root / probable cause code: personnel: training: inadequate. 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: at the time of this report, the disposition of the injector is currently unknown.
Event Description
This incident was reported by a facility in (b)(6) on (b)(6) 2020. Radiographer complained the ram turns backwords when using pfs product (single use). The backword of the ram causes the reflux of the blood while using the 125ml of optiray pfs in software (b)(4). Patient connected. No patient harm.
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Manufacturer (Section D)
2111 e. galbraith rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
cincinnati, OH 45237
MDR Report Key11020332
MDR Text Key229594418
Report Number1518293-2020-00041
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
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 11/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844001
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 Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage