MalfunctionMEB
INFUSOR
Received Jul 13, 2026 · Event occurred Jun 12, 2026
Report 1416980-2026-02314 · MDR key 25806637
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C1009KCatalog number
2C1009K
Lot number
25J012
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT 'THE FLOW LIMITER' OF A LARGE VOLUME INFUSOR LEAKED. THE ISSUE WAS IDENTIFIED DURING DEVICE CONFIGURATION, PRIOR TO PATIENT USE. THE DEVICE WAS FILLED WITH 180 ML OF FLUOROURACIL AND 60 ML OF SALINE. 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.