MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE L; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142120490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum y-type blood set, 200 micron filter, clave secondary port, secure lock, 110 inch where they reported that they are experiencing leaking in the administration set at the bottom on the filter.The reported also stated that there have been 2 reported incidents of leaking tubing.The first was identified during the priming of the set and resulted in the loss of a unit of blood.The second was identified by the nurse who inspected the product prior to the nurse spiking the blood bag.It was identified during blood transfusion and resulted in the loss of a unit of blood and a delay in care.The blood was infusing at the rate of 125ml/hr.And the leak was in the filter chamber.They stated that the leaks on both sets occurred in the bottom of the drip chamber at the weld between the clear plastic sidewalls of the drip chamber and the white hard plastic base of the drip chamber.There was no adverse event as a result of this event.
Additional Manufacturer Narrative
The device was reported not available for return, however, a lot review should be completed.
Additional Manufacturer Narrative
One video was provided for evaluation and it confirmed the complaint of leaking at the bottom on the filter chamber.The probable cause is stick down of the clave on the b port.The cause of the stick down was not provided by the investigator.The device history record was reviewed, no relevant nonconformities observed that would have contributed to this complaint.Corrected information can be found in e3 - initial reporter occupation and h6 - adverse event problem component codes.
Additional Manufacturer Narrative
One (1) video provided for evaluation; one (1) video provided, confirms the complaint of leaking at the bottom on the filter chamber.The reported complaint can be confirmed from the video provided.Probable cause is a defective weld/bond on the drip chamber.The device history review (dhr) for lot number 14205107 was reviewed, and no relevant nonconformities were observed that would have contributed to this complaint.

• Brand Name: PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE L
• 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: 22519174
• Report Number: 9615050-2025-00344
• Device Sequence Number: 7951833
• Product Code: FPA
• UDI-Device Identifier: 10887787006428
• UDI-Public: (01)10887787006428(17)280101(10)14205107
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2025

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: 142120490
• Device Lot Number: 14205107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 09/05/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/18/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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: BLOOD BAG ¿ MFR UNK.
• Patient Sex: Unknown