MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM SERIES 1000 INFUSION SETS; 1057 MRI SYRINGE ADAPTER SET

Model Number	1057
Medical Device Problem Codes	Defective Component (2292); No Flow (2991); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint came from a customer report of an observation of inlet occlusions in their response to the product correction notification.No patient injury was reported as part of the use of the defective device.Since this customer had not previously made iradimed aware of any issues prior to the recall being started, the customer recall response is being considered a new complaint.To be consistent with the original complaints that resulted in the recall this customer complaint is resulting in a mdr is being reported because the hhe associated with the original complaints determined that 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 is being considered a reportable event.
Event or Problem Description
Customer indicated in their response to recall z-1310-2023 that they had observed the problem described in the recall.No patient injury was reported, but this response is being treated as a new product defect report since iradimed was not aware of this customer's issue prior to their recall response.

• Brand Name: MRIDIUM SERIES 1000 INFUSION SETS
• Common Device Name: 1057 MRI SYRINGE ADAPTER SET
• 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: 16693856
• Report Number: 3005053560-2023-00010
• Device Sequence Number: 17670230
• Product Code: FPK
• UDI-Device Identifier: 10856038001048
• UDI-Public: 10856038001048
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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 Model Number: 1057
• Device Catalogue Number: 1057-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1310-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown