MalfunctionMEB
FOLFUSOR
Received Jun 24, 2026 · Event occurred May 27, 2026
Report 1416980-2026-02127 · MDR key 25613743
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
D2C4704KCatalog number
D2C4704K
Lot number
25C025
Product problems
- Material Rupture
Patient
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 INNER BAG(RESERVOIR) OF A SMALL VOLUME FOLFUSOR BURST CAUSING THE LIQUID TO LEAK INTO THE PUMP SHELL. THE ISSUE WAS DETECTED BEFORE APPLICATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.