BLOOD RECIPIENT SET
Received Apr 9, 2026 · Event occurred Mar 11, 2026
Report 1416980-2026-01244 · MDR key 24832327
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
JC7724Catalog number
JC7724
Lot number
R25J28130
Product problems
- Fluid/Blood Leak
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, H3, H4, H6 (UPDATE CODES), H11. H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND A SEPARATION BETWEEN THE HAND PUMP COMPONENT AND THE TUBING WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.
Description of Event or Problem
IT WAS REPORTED THAT A Y-TYPE BLOOD/SOLUTION SET ¿FELL APART¿ DURING INFUSION, RESULTING IN LEAKAGE. THE TUBING SEPARATED FROM BELOW THE FILTER CHAMBER. 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.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS ADDED TO D9: DATE RETURNED TO MFR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.