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	01/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 inch where it was reported that there were two reports of possible leaking from the filter when administering total parenteral nutrition (tpn) & lipids concurrently.The nurse noted a stain on the bed but couldn't see where the leak was, but then the 2nd time the nurse saw fluid underneath the filter as it laid in the bed.They saved the tubing and tried to replicate the leaking.They ran the pump from 9am-4pm.They did see one small drop of fluid on the outside of the filter after the rate titrated up to 133ml/hr.They wiped it so they could see where it came from, but the filter remained dry.The lipids they had ran out so for the rest of the test it was just the thinner iv fluids.The tubing used to replicate the issue was the same tubing that leaked on the 2nd incident.There was patient involvement, however, no adverse event and no delay in therapy as it was found at the end of the therapy, or tpn & lipids had to be stopped & child placed on alternative therapy.This captures 1 of 2 occurrences.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Possible lot numbers provided.Device history lot number review is pending.Plots: (b)(6) manufacturing date: 10/01/2024 expiration date: 10/01/2027.(b)(6) manufacturing date: 08/01/2024 expiration date: 08/01/2027.
Additional Manufacturer Narrative
The complaint of leaking from the filter could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history of the potential lots (14103836 & 14035850) were reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21472419
• Report Number: 9615050-2025-00093
• Device Sequence Number: 18321268
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIPIDS, UNK MFR.; TOTAL PARENTERAL NUTRITION, UNK MFR.
• Patient Sex: Unknown