FOLFUSOR
Received Jul 8, 2026 · Event occurred Jun 8, 2026
Report 1416980-2026-02268 · MDR key 25754688
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
M2C4711KCatalog number
M2C4711K
Lot number
25H015
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR LEAKED FROM AN UNSPECIFIED LOCATION, RESULTING IN A WHITE RESIDUE COATING ON THE PUMP ITSELF. THE ISSUE WAS NOTICED WHEN THE DEVICE WAS REMOVED FROM ITS PACKAGING, PRIOR TO PATIENT USE. THE DEVICE HAD BEEN FILLED WITH 3500 MG OF FLUOROURACIL (5-FU) IN 115 ML OF SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.