CLEARLINK
Received Feb 3, 2026 · Event occurred Jan 6, 2026
Report 1416980-2026-00464 · MDR key 24251375
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
DR25C06048
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B3/D10, D4 EXPIRATION DATE (UPDATE TO N/A), D9, H3, H4, H6 (UPDATE CODES), H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WHICH IDENTIFIED THE SPIKE DETACHED FROM THE TUBE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION IS RELATED TO ASSEMBLY PROCESS DURING MANUFACTURING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET CAME APART DURING PATIENT TRANSFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.