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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 Break (1069); Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary: injector gave pressure error twice while contrast was being injected. No pressure error noted when tested for patency. On third attempt of injection, the pressure sleeve of the face plate "popped". The procedure was completed with no impact or event experienced by patient. Service investigated the unit , doing a system flow rate and pressure check with out finding any pressure issues. Service replaced the 200 ml pressure sleeve and verified operation using service checklist 846130 and returned the unit to service. A review of cts shows no previously reported pressure sleeve breaks on this unit. Impact assessment summary: no injury to the patient/user reported. (b)(4). Root / probable cause code. Equipment/instrument - failure. Root / probable cause summary. Refer to investigation summary. 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 review and during the management review meetings to consider input for corrective action. Disposition summary: unit returned to service.
 
Event Description
This incident was reported by a facility in (b)(6) on (b)(6) 2022. The reporter states that the injector gave pressure error twice while contrast was being injected. No pressure error was noted when tested for patency. On third attempt of injection, the sleeve of the faceplate "popped". Reporter states that the patient was attached at the time and that the procedure was completed with intended dose, with no adverse impact or effect experienced by patient or staff.
 
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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 Key13505668
MDR Text Key288098130
Report Number1518293-2022-00002
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeSF
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 Inspection
Type of Report Initial
Report Date 01/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844005
Device Lot NumberC0712B536X
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2012
Is This a Reprocessed and Reused Single-Use Device? No

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