FOLFusor
Received Jul 30, 2026
Report 1416980-2026-02503 · MDR key 50091597
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C4008KCatalog number
2C4008K
Lot number
25H027
Product problems
- No Flow
Patient
Unknown
- Dyspnea
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
B3/D10 date: The event was observed between (b)(6) 2026.Should additional relevant information become available, a supplemental report will be submitted.
Description of Event or Problem
It was reported the patient experienced increased shortness of breath and decreased urine output during use of a Large Volume FOLFusor. The patient received subcutaneous furosemide administration after a poor response to oral treatment. After two days of use, the FOLFusor device was "not functioning" and the patient's urine output had decreased. Further treatment and patient outcome were not reported. No additional information is available.