MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM 1000 SERIES INFUSION SET; MRIDIUM 1057

Model Number	1057
Medical Device Problem Codes	Suction Problem (2170); Defective Component (2292); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the vent was not allowing air into the line for a set from lot 22j46n and the silicone section was collapsing due to vacuum being formed when pumping.No patient injury occurred.
Additional Manufacturer Narrative
No patient injury has been reported as part of the use of the defective device.This is one of several complaints that resulted in a capa investigation into the issue.After reviewing 1057 iv sets returned from customers with the complaints, it was determined that the syringe connector vent was blocked.In all the reported complaints, the customer indicated there was no patient injury, but that an inlet occlusion alarm had occurred resulting in the need to replace the infusion set.A health hazard evaluation (hhe) was performed as part of the investigation into the reported events, and although there have been no reports of injury, under certain sequence of events, the hazardous situations (underdose and/or delay of therapy) could lead to possible harms, including serious adverse health consequences.The hhe determined that the sequence of events that could lead to the hazardous situation has a remote probability of occurring, but due to the level of severity if it were to occur, it was determined that updates to the product labeling as part of a product field correction informing the user to verify proper venting of the 1057 set during the infusion set priming process was the appropriate action.Prior to the hhe, the level of risk of an inlet occlusion was not expected to result in serious adverse health consequences as the systems mitigations include providing visual and audible alarms for inlet occlusions.However, in consideration of the hhe's finding that serious adverse health consequences could occur in remote cases, the risk management file was revised with a higher severity level, thereby requiring medical device reporting per 21 cfr part 803 due to the potential of harm that may occur.The hhe was completed on 2/22/2023 and this is considered the date that the risk was re-evaluated resulting in a "become aware date" thereby triggering this mdr report of a product defect.

• Brand Name: MRIDIUM 1000 SERIES INFUSION SET
• Common Device Name: MRIDIUM 1057
• Manufacturer (Section D): IRADIMED CORPORATION; 1025 willa springs drive; winter springs FL 32708
• Manufacturer (Section G): IRADIMED CORPORATION; 1025 willa springs drive; winter springs FL 32708
• Manufacturer Contact: steven kachelmeyer ; 1025 willa springs drive; winter springs, FL 32708 ; 4076778022
• MDR Report Key: 16585712
• Report Number: 3005053560-2023-00002
• Device Sequence Number: 4694086
• Product Code: FPK
• UDI-Device Identifier: 10856038001048
• UDI-Public: 10856038001048
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 1057
• Device Catalogue Number: 1057-50
• Device Lot Number: 22J46N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: EVENT 91846
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown