NI
Received Feb 18, 2026
Report 3006755813-2026-00008 · MDR key 24379168
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
ASKU
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3: THE EVENTS OCCURRED PRIOR TO CHRISTMAS IN YEAR 2025. D4: LOT #: A POTENTIAL LOT MAY BE 24S16T326 WHICH IS NOT A VALID LOT RECOGNIZED BY BAXTER. E1: INITIAL REPORTER POSTAL CODE: (B)(6). H11: THE DEVICES WERE DISCARDED AND THE POTENTIAL LOT IS NOT VALID; 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 AT LEAST THREE (3) UNKNOWN BLOOD - SOLUTION SETS LEAKED. THE LOCATION WAS DESCRIBED AS "NEAR THE TOP OF THE CHAMBER", "BONDED JOINTS. TUBE TO LUER CONNECTOR AND TUBE TO CHAMBER" OR FROM "BODY OF THE CHAMBER". THE ISSUE WAS OBSERVED BEFORE PATIENT TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.