NI
Received Feb 19, 2026
Report 3006755813-2026-00011 · MDR key 24389455
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3: THE EVENTS OCCURRED IN UNSPECIFIED DATE OF JANUARY 2026. E1: INITIAL REPORTER POSTAL CODE: (B)(6). H11: THE DEVICES WERE DISCARDED AND THE LOT NUMBER IS UNKNOWN; 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 AN UNSPECIFIED QUANTITY OF 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. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.