inforMED
MalfunctionMEB

FOLFusor

Received Jul 31, 2026 · Event occurred Jul 3, 2026

Report 1416980-2026-02513 · MDR key 50105068

Device

Generic name

Pump, Infusion, Elastomeric

Model number

M2C4063K

Catalog number

M2C4063K

Lot number

25G030

Product problems

  • No Flow

Patient

56 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported that a Large Volume FOLFusor did not fully infuse the antibiotic during patient infusion via PICC (peripherally inserted central catheter). The device was filled with piperacillin/tazobactam 18000 mg in 230 mL of 0.9% sodium chloride (NaCl). The infusion could not be completed. There was no report of patient injury or medical intervention associated with this event. No additional information was available.

Additional Manufacturer Narrative

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