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 Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation but a lot history review will be conducted.
Event or Problem Description
The event involved a primary y-type blood set, 200 micron filter, bulb pump, clave y-site, secure lock, 80 inch where the customer reported that the device separated during patient infusion.It was reported that when they attempt to purge the air in the bulb back towards the filter, the tubing came apart.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Three pictures were returned.Two showed the incoming tubing detached from bulb pump on the set.One showed the lot information of the set.The complaint of tubing coming apart can be confirmed based on the returned images.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21072192
• Report Number: 9615050-2025-00009
• Device Sequence Number: 3409975
• Product Code: FPA
• UDI-Device Identifier: 10887787005360
• UDI-Public: (01)10887787005360(17)270701(10)14054391
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 124350489
• Device Lot Number: 14054391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Patient Sex: Unknown