MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	15687-28
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
An email was received regarding a primary plum set, clave secondary port, clave y-site, secure lock, 128 inch in which it was reported the device leaked at the y-site.It was reported that the registered nurse (rn) stated the tubing on l1 of the device had been hung on (b)(6) 2026 at 05:17 with vasopressin running at 0.03 u per min (4.5 ml per hr) during the day shift.On (b)(6) 2026, the clinical coordinator not the bedside rn reported that the patient vitals required the addition of another medication, phenylephrine, which was connected to the y-site on the tubing.According to the rn, the phenylephrine infusion had to be titrated from 20 mcg per min to 250 mcg per min between 16:30 and 18:35, at which time it was discovered that the tubing was leaking at the y-site.The tubing was replaced at that time.The clinical coordinator confirmed the leak by attaching a bag of saline and observed fluid leaking below the bonded clave at the lower y-site.The patient was reported to be stable as of (b)(6) 2026 at 09:45.It was unclear if there was any impact to the patient at the time of the events on 18-mar-2026, as the reporting rn stated that the patient¿s condition required multiple medication adjustments.The tubing has been saved in a bag by the facility contact.It was reported that the patient has passed away.Vasopressin was being delivered through the tubing at 40 mg per 100 ml saline.The patient¿s blood pressure was trending down, and the rn titrated other medication to support blood pressure.After checking all lines, it was noticed that the vasopressin line had a leak at the distal y-site, and his bed was wet.The tubing was changed, and the patient¿s blood pressure increased.The customer clarified that they were not indicating the tubing issue caused the patient¿s death.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24750073
• Report Number: 9615050-2026-00216
• Device Sequence Number: 10215146
• Product Code: FPA
• UDI-Device Identifier: 00887709102460
• UDI-Public: (01)00887709102460(17)280301(10)14272708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 15687-28
• Device Lot Number: 14272708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PHENYLEPHRINE, MFR UNKNOWN; PLUM DUO, SERIAL NUMBER: 80010840, ICU MEDICAL; VASOPRESSIN, MFR UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Race: White