MalfunctionMEB
FOLFusor
Received Jun 26, 2026
Report 1416980-2026-02170 · MDR key 25643973
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
M2C4711K
Lot number
25H015
Product problems
- Filling Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ELASTOMERIC DEVICES UNDER INFUSED DURING INFUSION. IT WAS OBSERVED THAT THE FLUOROURACIL PUMPS HAD FLUID REMAINING IN THE BALLOON AT THE TIME THE INFUSION WAS EXPECTED TO BE COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.