inforMED
MalfunctionBRZ

NA

Received Oct 8, 2024 · Event occurred Jun 16, 2024

Report 20395449 · MDR key 20395449

Device

Generic name

Set, Blood Transfusion

Model number

2C7627

Catalog number

2C7627

Lot number

R23E26093

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PER PRIMARY RN, [REDACTED NAME], TUBING FOR BLOOD TRANSFUSION WAS INEFFECTIVE. PATIENT WAS NOT ABLE TO RECEIVE FULL TRANSFUSION, PER RN 175ML TRANSFUSED. TUBING NOT AVAILABLE TO SUBMIT, PLACED IN BIOHAZARD AT COMPLETION OF TRANSFUSION. TUBING: Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER LOT# R23E26093. NO EXPIRATION DATE FOUND ON PACKAGING. PER MANAGER: THE MAIN ISSUE MY STAFF IS HAVING WITH THIS TUBING IS THAT PER THE LMS (HEALTHCARE LEARNING MANAGEMENT SYSTEM) THEY DO NOT NEED TO PRIME THE TUBING WITH NORMAL SALINE, BUT IF THEY DO NOT IT SEEMS LIKE THE BLOOD PRODUCT DOES NOT EFFECTIVELY INFUSE. MANUFACTURER RESPONSE FOR IV TUBING, Y-TYPE BLOOD/SOLUTION SET WITH STANDARD BLOOD FILTER (PER SITE REPORTER).