inforMED
MalfunctionBRZ

CLEARLINK

Received Sep 9, 2025 · Event occurred Aug 13, 2025

Report 23004094 · MDR key 23004094

Device

Generic name

Set, Blood Transfusion

Model number

2C8750

Catalog number

2C8750

Lot number

(10)DR25C19031

Product problems

  • Insufficient Flow or Under Infusion

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

BLOOD TRANSFUSION HAD BEEN STARTED IN THE 1800 HOUR, AND WAS INFUSING DURING BSSR [BEDSIDE SHIFT REPORT]. STAFF NOTED BLOOD DRIPS IN CHAMBER AT REGULAR INTERVALS. THE RATE WAS SET AT 150 ML/HR. HOWEVER, WHEN THE 4 HOUR TIME LIMIT (2230) WAS APPROACHING, THE BAG WAS ONLY APPROXIMATELY HALF EMPTY. THE CLAMP TO THE BLOOD LINE WAS FULLY OPEN AND THE CLAMP TO THE NS [NORMAL SALINE] WAS FULLY CLOSED. THE NS BAG WAS MORE THAN HALF EMPTY, AND THE BLOOD LOOKED THINNER AND MUCH PALER THAN IS NORMAL FOR A UNIT OF PRBC [PACKED RED BLOOD CELLS].