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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 Problems Inaccurate Delivery (2339); Activation, Positioning or SeparationProblem (2906); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
This incident was reported by a facility in utrecht, netherlands on (b)(6) 2021. The reporter states that after upgrading 2 optivantages error code 2048 (miscellaneous software alarm) is coming up several times. After starting the injector up it goes well for some time and then comes up again. The last time the injector failed during an injection. Reporter states that during the injection of the contrast the injector stopped. At that moment patient had not received enough contrast to make a good picture, therefore, they did not start the scanning. Facility restarted the injector, and then inject another doses of contrast, at the end the patient did become 50cc contrast more than was planned. Reporter states that the kidney function of this patient is ok, not a problem for this patient, and that the procedure completed.
 
Manufacturer Narrative
Overall investigation summary incident: after upgrading 2 optivantages error code 2048 (miscellaneous software alarm) was coming up several times. During the injection of the contrast this injector stopped. They restarted the injector. Procedure completed. Regional service gave loan injectors to the customer(s). Service reported: "the factory (technician) did not find a cause of error 2048, therefore they removed the oem interface pcb's (b)(4), as this solved the problem in previous cases. " the customer units are currently in the workshop as the loaner units are in use. Cts history search shows no other similar issues with this unit. Impact assessment summary (b)(4). Equipment/instrument software 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. "the factory (technician) did not find a cause of error 2048, therefore they removed the oem interface pcb's (b)(4), as this solved the problem in previous cases. " the customer units are currently in the workshop as the loaner units are in use.
 
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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 Key12909693
MDR Text Key283779770
Report Number1518293-2021-00039
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K063503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844005
Device Lot NumberCI0512B556
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2012
Is This a Reprocessed and Reused Single-Use Device? No

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