INFUSOR
Received Jul 27, 2026 · Event occurred Jun 11, 2026
Report 1416980-2026-02441 · MDR key 50027608
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
J2C1711Catalog number
J2C1711
Lot number
25M003
Product problems
- No Flow
Patient
Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that a Small Volume Infusor exhibited a slow flow rate, resulting in almost all or a large amount of the 110 mL solution remaining in the device during patient infusion. The device was filled with 46 mL of 5-Fluorouracil (5-FU) and 69 mL of saline having a total volume of 115 mL. The expected infusion duration was 46 hours. 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.