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	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) used list# 125390490, primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 inch for inspection.The filter vents on the used 1.2 micron filter were wetted out with prior infusate.The set was tested per product specifications.As received, there was leakage from the 1.2 micron filter.The reported complaint of leakage on the 1.2 micron filter can be confirmed.The probable cause of the leakage is due to a temporary or complete loss of hydrophobic properties due to prior infusate interaction.Lot history review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
The event involved primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 inch where the customer reported that the device was leaking tpn/lipids at the filter.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
D4 - plots - possible lot numbers - 14035850 and 14103836 14035850 - manufacture date: 8/1/2024 expiration date: 08/01/2027 and 14103836 - manufacture date: 10/01/2024 expiration date: 10/01/2027.

• 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: 21733021
• Report Number: 9615050-2025-00140
• Device Sequence Number: 4147871
• Product Code: FPA
• UDI-Device Identifier: 10887787005407
• UDI-Public: 10887787005407
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown