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

Model Number 844005

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: incident: injection releasing serum along with contrast.Problem occurred during procedure with patient connected however was not any injury or damage.Regional service was informed (by) client that the injector was injecting serum and contrast together.Service was informed that they found traces of contrast in the pre-contrast phase of a patient and according to the nursing team this happened only once.Service reported the customer uses manyfill and was instructed on the proper use of it (always wash the entire circuit with saline at each patient change).Service checked for proper operation - conducted performance & calibration tests, and the equipment was approved in all tests according to the checklist.No problem was found and the equipment was released for use.Cts history search shows no other similar issues with this unit.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: service checked for proper operation - conducted performance & calibration tests, and the equipment was approved in all tests according to the checklist.No problem was found and the equipment was released for use.

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2021.The customer reported the following: incident: injection releasing serum along with contrast.Problem occurred during procedure with patient connected however was not any injury or damage.

• 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: 12274106
• MDR Text Key: 267024857
• Report Number: 1518293-2021-00017
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: 505
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: C0820B963G
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1