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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 Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary: incident: pump stopped. Regional service performed analysis of the equipment, and found it presented error 2048 flashing until the moment it turned off and did not turn on again. Service carried out internal inspection of powerhead and found excess contrast in the cable connectors. The powerhead plate (ph pcb ass'y, 844375-1) was replaced; software was updated, and unit was returned to normal operation. Service also performed necessary calibrations, which were ok and carried out performance tests (pm) as checklist and the equipment was fit for use. Cts history search shows no other similar issues with this unit. Impact assessment summary: n/a. Root / probable cause code: materials - contamination. 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: service replaced powerhead plate (ph pcb ass'y, 844375-1); software was updated, and unit was returned to normal operation. Service also performed necessary calibrations, which were ok and carried out performance tests (pm) as checklist and the equipment was fit for use.
 
Event Description
This incident was reported by a facility in (b)(6) on (b)(6) 2021. The customer reported that the pump stopped, and that the problem occurred during a procedure while the patient was connected. Reporter states that there was no injury or damage to patient. They do not know the amount of contrast that was injected. Reporter also states that the procedure was repeated.
 
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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 Key12482890
MDR Text Key272914603
Report Number1518293-2021-00028
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeBR
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 Repair
Type of Report Initial
Report Date 07/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844003
Device Lot NumberC0413B508X
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 Received07/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2013
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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