MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	124350489
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Flow (2991)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for investigation however a device history review and photo review should be performed, and a supplemental report will be submitted.
Event or Problem Description
The event occurred on an unspecified date involving a primary y-type blood set, 200 micron filter, bulb pump, clave y-site, secure lock, 80 inches, and it was reported that there were issues with the tubing, with blood backing up into the lines and leaking from the ports.The bulb being very hard to squeeze when administering a bolus.There were patient involvement and patient harm.The event occurred during administration of intravenous (iv) therapy and most of the events are noted in post-anesthesia care unit (pacu).The blood back flowed into the tubing and in some cases to the bulb and blood had passed the stopcocks.There was a delay in therapy in which patient was hypotensive requiring fluid bolus in pacu.Once the tubing was exchanged, the hypotension was corrected, and the patient was able to be discharged home.The iv fluid is infused via peripheral line placed on the day of surgery.Pacu iv fluid is infused at a rate of 125ml per hour and patient has received 3 doses of ephedrine in pacu.

• Brand Name: PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOC
• 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: 25466241
• Report Number: 9615050-2026-00469
• Device Sequence Number: 18693363
• Product Code: FPA
• UDI-Device Identifier: 10887787005360
• UDI-Public: (01)10887787005360(17)290101(10)14848433
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K143087
• 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
• Report Date (Section B): 06/11/2026

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: 124350489
• Device Lot Number: 14848433
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: EPHEDRINE, UNK MFR.; UNSPECIFIED IV FLUID, UNK MFR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown