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
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a primary plum y-type blood set, 200 micron filter, clave secondary port, secure lock, 110 inch generated a leak during patient use.The reporter stated that there was leaking blood in the cartridge, it contaminated the intravenous (iv) pump, and it may have resulted in contamination to the patient.The patient needed additional intervention to prevent harm.They were unable to do a blood transfusion resulting in the patient not getting the necessary blood for four days.They had to discard the unit of blood that the patient needed and the tubing.It took over four days to get the blood type for the patient.They had to put the patient on antibiotics for closer to 10 days.

• 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: 19590517
• Report Number: 9615050-2024-00488
• Device Sequence Number: 3328009
• Product Code: FPA
• UDI-Device Identifier: 10887787006428
• UDI-Public: (01)10887787006428(17)261201(10)13776121
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

1 Device 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: 142120490
• Device Lot Number: 13776121
• 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: 05/22/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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