CE FOLFUSOR LV
Received Jul 13, 2026 · Event occurred Jun 4, 2026
Report 1416980-2026-02304 · MDR key 25798016
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4008KCatalog number
2C4008K
Lot number
24B001
Product problems
- Filling Problem
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A CE FOLFUSOR LV OVERINFUSED A FLUROURACIL INFUSION. THE PATIENT WAS ADMITTED TO THE DAY HOSPITAL TO RECEIVE A DAY 1, CYCLE 5 FLUROURACIL THERAPY ADMINISTERED VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE EXPECTED INFUSION DURATION WAS FIVE (5) DAYS. HOWEVER, THE INFUSION PUMP REPORTEDLY DID NOT INITIALLY APPEAR TO DEFLATE AND SUBSEQUENTLY EMPTIED IN LESS THAN 24 HOURS. AS A RESULT, THE PATIENT REPORTEDLY DEVELOPED POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES), WITH VISIBLE MOTOR AND NEUROLOGICAL SEQUELAE. NO ADDITIONAL INFORMATION IS AVAILABLE.