FOLFUSOR
Received Jul 13, 2026 · Event occurred Jun 15, 2026
Report 1416980-2026-02309 · MDR key 25803792
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
M2C4063KCatalog number
M2C4063K
Lot number
25D026
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME FOLFUSOR HAD LIQUID/DROPLETS INSIDE THE YELLOW BAG. THE ISSUE WAS IDENTIFIED PRIOR TO USE DURING DISPENSING AND CHECKING OF THE DEVICE. THE DEVICE WAS FILLED WITH 13500 MG OF PIPERACILLIN/TAZOBACTAM IN 230 ML 0.9% SODIUM CHLORIDE WITH CITRATE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.