MAUDE Adverse Event Report: ICU Medical Costa Rica Ltd. Primary PLUM Set, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 103 Inch; Set, administration, intravascular

Catalog Number	14687-28
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch reported that when rn was back priming secondary and noted leaking at the cassette.Rn stopped back priming and clamped secondary line due to dripping.Upon further inspection, it was found that there was a crack in the connector from the secondary to the cassette under the blue piece.The rn opened the chamber of the pump, and the connector broke off from the cassette, staying attached to the secondary line.The event occurred during priming.
Additional Manufacturer Narrative
Received one (1) used.List #14687-28.Primary plum set and one (1) used.List #unknown.Chemolock connector with one (1) used.List #unknown.Chemolock connector and one (1) used.List #unknown.Extension set with drip chamber and one (1) used.List #unknown.Chemolock connector for evaluation.As received the secondary port clave was separated and broken off of the cassette.A dhr lot # review could not be conducted because no lot numbers were identified.A rigid and uneven break was observed on the cassette and the clave port, indicative of a bending force.The complaint of cracked clave can be confirmed.The probable cause is due to an unintentional bending force.

• Brand Name: Primary PLUM Set, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 103 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: 50871967
• Report Number: 9615050-2026-01455
• Device Sequence Number: 15758946
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 14687-28
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• 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
• Patient Sex: Unknown