MalfunctionMEB
INFUSOR
Received Jun 17, 2026 · Event occurred May 19, 2026
Report 1416980-2026-02052 · MDR key 25532265
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
J2C1711Catalog number
J2C1711
Lot number
25K026
Product problems
- Failure to Infuse
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT FLUID DELIVERY FROM A SMALL VOLUME INFUSOR STOPPED DURING PATIENT INFUSION. THE DEVICE CONTAINED 5-FLUOROURACIL. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.