inforMED
MalfunctionBRZ

BLOOD RECIPIENT SET

Received Jul 10, 2026 · Event occurred May 29, 2026

Report 1416980-2026-02289 · MDR key 25784407

Device

Generic name

Set, Blood Transfusion

Model number

JC7751

Catalog number

JC7751

Lot number

DR25L17086

Product problems

  • Fluid/Blood Leak

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A BLOOD RECIPIENT SET LEAKED AT THE UPPER JUNCTION BETWEEN THE TUBING AND THE BLOOD FILTER CHAMBER. THE ISSUE WAS IDENTIFIED FIVE (5) MINUTES AFTER INITIATION OF A BLOOD TRANSFUSION, AT WHICH TIME THE TRANSFUSION WAS STOPPED IMMEDIATELY. THE REPORTED INFUSION RATE WAS 75 ML/HOUR. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.