MalfunctionBRZ
CLEARLINK
Received Nov 8, 2024 · Event occurred Aug 26, 2024
Report 20639728 · MDR key 20639728
Device
Generic name
Set, Blood Transfusion
Manufacturer
Baxter Healthcare CorporationModel number
2C8750Catalog 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.