MalfunctionMEB
INFUSOR
Received Jun 24, 2026 · Event occurred May 25, 2026
Report 1416980-2026-02125 · MDR key 25611708
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
J2C1711Catalog number
J2C1711
Lot number
25J004
Product problems
- Excess Flow or Over-Infusion
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SMALL VOLUME INFUSOR COMPLETED EARLIER THAN EXPECTED, WITH AN ADMINISTRATION TIME OF APPROXIMATELY 38 HOURS. THE DEVICE WAS FILLED WITH 5 FLUOROURACIL AND SALINE. THIS OCCURRED DURING PATIENT INFUSION. 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.