inforMED
MalfunctionMEB

FOLFusor

Received Jul 30, 2026

Report 1416980-2026-02493 · MDR key 50078311

Device

Generic name

Pump, Infusion, Elastomeric

Model number

2C4087K

Catalog number

2C4087K

Lot number

26C003

Product problems

  • No Flow

Patient

Unknown

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

It was reported that a Large Volume FOLFusor had no flow during patient use, resulting in lack of administration of the infused medication. The device was filled with furosemide/morphine, midazolam and was being administered subcutaneously (SC). The patient was receiving palliative sedation therapy; however, the desired sedation was not achieved. It was not reported whether any medical intervention was required. No additional information was available.

Additional Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.