MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LS PRIM PLUMSET-SL PE-LINED; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	123390488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it has not yet been received.Additional contact information (b)(6).
Event or Problem Description
An incident involving a primary plum set, orange polyethylene lined light resistant tubing, clave y-site, secure lock, 103 inch reported that leakage at the filter vent occurred during infusion.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
D9 - date returned to mfg: 1/14/2026 received one (1) used.List #123390488, primary plum set with one (1) used.List #unknown, quadfuse admin set connected to one (1) used.List #unknown, 50ml norm-saline 100ml bag with one (1) used.List #unknown, 50ml norm-saline 250ml bag connected one (1) used.List #unknown, 50ml norm-saline 500ml bag for inspection.As received, the filter was wetted out.Received one (1) photo of the set in a bag.The set was leak tested per specifications and no leakage was observed.The complaint of a leakage cannot be replicated but can be confirmed due to the wetted out filter.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter material due to an infusate interaction during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: LS PRIM PLUMSET-SL PE-LINED
• 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: 23799935
• Report Number: 9615050-2025-00610
• Device Sequence Number: 9360389
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)280301(10)14272782
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 123390488
• Device Lot Number: 14272782
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/14/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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: IRINOTECAN, UNK MFR.
• Patient Sex: Unknown