inforMED
MalfunctionBRZ

CLEARLINK

Received Nov 8, 2024 · Event occurred Aug 26, 2024

Report 20639728 · MDR key 20639728

Device

Generic name

Set, Blood Transfusion

Model number

2C8750

Catalog number

2C8750

Lot number

(10)DR23K29031

Patient

65 YR · Unknown

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

Narrative

Description of Event or Problem

PATIENT WAS GETTING TUMOR-INFILTRATING LYMPHOCYTE (TIL) THERAPY, LIFILEUCEL. PRODUCT IS RUN THROUGH BLOOD TUBING. REGISTERED NURSE (RN) WAS SWITCHING THE EMPTY SECOND BACK FOR THE FULL THIRD AND FINAL BAG OF THE PRODUCT. AFTER SPIKING THE BAG TO HANG IT, THE TUBING CONNECTED TO THE BAG SPIKE CAME LOSE AND FELL OUT. WE REMOVED THE DETACHED BAG SPIKE AND USED ANOTHER BLOOD TUBING SET WIT NO ISSUES. NO PATIENT OR STAFF HARM.