CLEARLINK
Received Mar 16, 2026 · Event occurred Feb 15, 2026
Report 1416980-2026-00964 · MDR key 24611807
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
DR25F11024
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5 (CLARIFICATION): THE LEAK WAS OBSERVED DURING ADMINISTRATION WITH BLOOD PRODUCT; THE BLOOD PRODUCT WAS LEAKING. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICES WERE NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS LEAKED BLOOD AROUND THE HUB (CLEARLINK), ONTO FLOOR AND WITHIN BLOOD WARMER. THE ISSUE OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.