MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	125390490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Event or Problem Description
The tubing of a primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 inch was reportedly wet due to leakage of an unspecified fluid/infusate during use on a patient.The pressure on the infusion pump was checked (while it was still infusing) and it was at 1.8, therefore, no high pump pressure was noted.The leak was coming from the circle on the flat side of the filter, and not the side where the tubing connects.There was no harm to the patient that was involved in the event.

• Brand Name: PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24654234
• Report Number: 9615050-2026-00209
• Device Sequence Number: 5726268
• Product Code: FPA
• UDI-Device Identifier: 10887787005407
• UDI-Public: (01)10887787005407(17)281101(10)14576672
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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 Catalogue Number: 125390490
• Device Lot Number: 14576672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID/INFUSATE, MFR UNK.; UNSPECIFIED PLUM INFUSION PUMP, MFR ICU MEDICAL.
• Patient Sex: Unknown