MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY BLOOD SET, 200 MICRON FILTER, PREPIERCED Y-SITE, SECURE LOCK, 80 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126940488
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary blood set, 200 micron filter, pre pierced y-site, secure lock, 80 inch where it was reported that the blood administration set was throwing air bubbles.Device was discarded.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of blood administration set throwing air bubbles could not be confirmed by investigation.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.Additional reporter: (b)(6).

• Brand Name: PRIMARY BLOOD SET, 200 MICRON FILTER, PREPIERCED Y-SITE, SECURE LOCK, 80 INCH
• 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: 19239942
• Report Number: 9615050-2024-00355
• Device Sequence Number: 7061980
• Product Code: FPA
• UDI-Device Identifier: 10887787008811
• UDI-Public: (01)10887787008811(17)250601(10)5973293
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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 Expiration Date: 06/01/2025
• Device Catalogue Number: 126940488
• Device Lot Number: 5973293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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