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	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
An email was received regarding a primary plum set, orange polyethylene lined light resistant tubing, clave y-site, secure lock, 103 inches generated a leak during patient use.It was stated in the report that leakage at the filter vent.Cisplatin was involved in the event.The event was noted during infusion.There was patient involvement, but no patient was harmed.There was no chemotherapy exposure.
Additional Manufacturer Narrative
Investigation summary: received one (1) used.List #unknown, 500 ml intravenous bag with cisplatin with one (1) used.List #unknown, clave bag spike connected to one (1) used.List #norm-saline injection otsuke 250 ml with one (1) used.List #unknown, dry spike adapter with 4 spiros and bag spike connected to one (1) used.List #(b)(4), primary plum set with one (1) used.Ref #(b)(4), terumo disposable syringe 10 cc/ml for inspection.As received, the filter was wetted out.Received two (2) photos, one (1) photo of the filter cap open and the filter wetted out and one (1) photo of the 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, 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: 23811184
• Report Number: 9615050-2025-00612
• Device Sequence Number: 20760149
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)280501(10)14338114
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 14338114
• 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: 02/02/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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
• Patient Sex: Unknown