MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142550489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved a primary plumset, 0.2 micron filter, clave y-site, pe lined tubing, 104 inch where it was reported that leakage occurred from the air vent hole of the rectangular filter.During the leqembi infusion, a small amount of leakage was observed when fluid dripped onto the patient¿s pants and during the kisunla infusion, a more significant leakage was noted, estimating approximately 5 ml of fluid loss, it was delivered at the rate of 277 ml/hr.The drug was infused via peripheral and the concentration was860 mg in 250 ml (3.44 mg/ml).The leakage began almost immediately after the infusion was initiated.There was patient involvement, and no harm reported.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.(b)(6).

• Brand Name: PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 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: 25180280
• Report Number: 9615050-2026-00288
• Device Sequence Number: 10385020
• Product Code: FPA
• UDI-Device Identifier: 10887787005971
• UDI-Public: (01)10887787005971(17)281201(10)14632604
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: 142550489
• Device Lot Number: 14632604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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: KISUNLA, UNK MFR; LEQEMBI, UNK MFR
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 87 KG