CLEARLINK
Received Nov 14, 2025 · Event occurred Oct 17, 2025
Report 1416980-2025-05667 · MDR key 23552736
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog number
2C8750
Lot number
DR25D07055
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4: EXPIRATION DATE (UPDATE THE N/A), D9, H3, H4, H6(UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND OBSERVED THAT THE FILTER WAS BROKEN. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED, HOWEVER WAS MOST LIKELY RELATED TO PRODUCT HANDLING BY THE USER DURING THE INSTALLATION PROCESS. 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
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT TWO (02) CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WERE BROKEN AT THE CONNECTION POINT BETWEEN THE BLOOD FILTER CHAMBER AND THE TUBING. THIS WAS DISCOVERED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.