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	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Initial reporter (full) phone: (b)(6).
Event or Problem Description
The complaint/event involved a primary plum y-type blood set, 200 micron filter, clave secondary port, secure lock, 110 inch.Leakage was reported under the filter chamber during a blood transfusion of packed red blood cells.For this incident, the patient was awake and notified the rn that there was blood dripping out of the tubing.There was no adverse event or harm; however, there was delay in therapy when they have to re-prime another tubing set.The blood that was primed in the other set was technically wasted and the patient did not receive it.This report reflects 1 of 2 occurrences.
Additional Manufacturer Narrative
Corrected information can be found in e1 - initial reporter postal code.
Additional Manufacturer Narrative
Received: one (1) new list# 142120490, primary plum y-type blood set, 200 micron filter, clave secondary port, secure lock, 110 inch.As received, the set was visually inspected, and no anomalies were found.The set was air pressure leak tested, and no leaks were found.The used/affected set was not returned for evaluation.Without the return of the used sample, a comprehensive investigation cannot be performed.The complaint cannot be confirmed on the returned, new set.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported 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: 22159202
• Report Number: 9615050-2025-00281
• Device Sequence Number: 8906566
• Product Code: FPA
• UDI-Device Identifier: 10887787006428
• UDI-Public: (01)10887787006428(17)270701(10)14046341
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/21/2025

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: 14046341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 06/24/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/06/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNIT OF PRBC (PACKED RED BLOOD CELLS), MFR UNK
• Patient Sex: Unknown