MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 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	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a primary plumset, pe lined tubing, 107 inch that experienced leakage.It was stated in the report that there was a water leakage from the cap above the drip chamber.Patient involvement and patient harm/adverse event are unknown.Sample picture is available.There is one quantity affected and one sample is returning for investigation.No further information is available for this complaint.
Additional Manufacturer Narrative
D9 - date returned to mfg: 4/9/2025.One (1) photo was provided by the customer, circling the drip chamber filter vent as the location of the leak.Received one (1) used.List #142480489 primary plumset attached to a spiros bag spike adapter.As received no visual defects or anomalies were noted.The set was attached to an icu medical-provided intravenous (iv) bag, primed per packaging directions, and an infusion test was performed using an icu plum pump.There was no cassette errors, occlusion alarms, or air-in-line alarms generated and no restrictions in flow or leaks/drips were observed.Unable to confirm customer complaint of drips below the drip chamber.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUMSET, PE LINED TUBING, 107 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21733949
• Report Number: 9617594-2025-00597
• Device Sequence Number: 8735493
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• UDI-Public: (01)10887787006183(17)270301(10)13875178
• 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): 06/09/2025

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: 13875178
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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
• Patient Sex: Unknown