MalfunctionMEB
FOLFUSOR
Received Jul 17, 2026 · Event occurred Jun 7, 2026
Report 1416980-2026-02357 · MDR key 25855007
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4711KCatalog number
2C4711K
Lot number
25K021
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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 SMALL VOLUME FOLFUSOR UNDERINFUSED DURING PATIENT INFUSION. THE EXPECTED INFUSION TIME WAS 48 HOURS; HOWEVER, THE DEVICE WAS DISCONNECTED AFTER APPROXIMATELY 60 HOURS OF INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.