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	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plumset, pe lined tubing, 107 inch.It was reported that even after pressing the stop button, the medicine keeps flowing and won't stop.This issue led to over delivery during infusion.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
E1 - initial reporter phone is (b)(6).Received one (1) photo of the set in a bag.No evidence of unrestricted flow was observed.The complaint of unrestricted flow cannot be replicated or confirmed without the return of the used set.The lot history could not be reviewed due to no lot number being provided.

• 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 NA ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50883060
• Report Number: 9615050-2026-01477
• Device Sequence Number: 15909142
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 142480489
• Device Lot Number: 14886528
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown