FOLFUSOR
Received Jun 18, 2026
Report 1416980-2026-02072 · MDR key 25542572
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4009KCatalog number
2C4009K
Lot number
NI
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TWO LARGE VOLUME FOLFUSORS COMPLETED THE INFUSION LATER THAN EXPECTED. THE INFUSION ENDED AFTER 1 HOUR 30 MINUTES AND 9 HOURS 30 MINUTES AFTER THE SCHEDULED TIMES RESPECTIVELY. THE ISSUE WAS NOTICED AFTER PATIENT USE. THE DEVICES WERE FILLED WITH 5-FLUOROURACIL (5-FU). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.