MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, PE LINED TUBING, 107 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142480489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.The investigation is pending.
Event or Problem Description
The event involved a primary plumset, pe lined tubing, 107 inch where a leakage of a chemo drug inside the tube line that reached on the iv pump was reported.The event occurred during infusion, there was patient involvement and no patient harm.There were 2 mating devices connected to the complaint products.The list numbers for mating devices are ch3034, 011-c32029.No complaints reported on these mating devices.
Additional Manufacturer Narrative
Received one used.List #142480489, primary plumset, pe lined tubing, 107 inch, one used.List #unknown, bag spike adapter with spiros; one used.List #unknown, extension set with filter, as received, the 0.2 micron filter appeared to be wetted out with infusate residuals.The plum set was leak tested, and a leak was observed at the 0.2 micron filter outlet.Confirmed the customer complaint of leaking, probable cause is due to a loss of hydrophobic properties resulting from an infusate interaction during use.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to mfr 4/9/2025.

• Brand Name: PRIMARY PLUMSET, PE LINED TUBING, 107 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: 21748816
• Report Number: 9615050-2025-00144
• Device Sequence Number: 9537474
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• UDI-Public: (01)10887787006183(17)270501(10)13935303
• 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): 06/12/2025

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: 142480489
• Device Lot Number: 13935303
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: ICU MEDICAL #011-C32029, 22 CM (8.5") EXT SET W/0.; ICU MEDICAL #CH3034, 5" (13 CM) BAG SPIKE ADAPTER.; UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown