MalfunctionMEB
INFUSOR
Received Jun 29, 2026 · Event occurred Jun 1, 2026
Report 1416980-2026-02193 · MDR key 25661866
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 A SMALL VOLUME INFUSOR HAD NO FLOW. THE ISSUE WAS IDENTIFIED AFTER FILLING BEFORE CONNECTING TO THE PATIENT. THE DEVICE WAS CONTAINED 5-FLUOROURACIL (5-FU). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.