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

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.

• Brand Name: INJ. OPTIV DH,SI W/OEM
• Type of Device: INJ. 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 Key: 13505668
• MDR Text Key: 288098130
• Report Number: 1518293-2022-00002
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 844005
• Device Lot Number: C0712B536X
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female