INFUSOR
Received Jun 25, 2026 · Event occurred May 26, 2026
Report 1416980-2026-02132 · MDR key 25620202
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
J2C1711Catalog number
J2C1711
Lot number
25J004
Product problems
- No Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH A SMALL VOLUME INFUSOR. THE ISSUE WAS IDENTIFIED WHEN THE PATIENT, WHO HAD RECEIVED THE INFUSER, CONTACTED THE HOSPITAL TWO DAYS LATER REPORTING NO APPARENT CHANGE IN THE BLADDER. THE DEVICE WAS FILLED WITH FLUOROURACIL AND 5% DEXTROSE. 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.