INFUSOR
Received Jul 1, 2026 · Event occurred Apr 10, 2026
Report 1416980-2026-02212 · MDR key 25686208
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2009KCatalog number
2C2009K
Lot number
NI
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED MEDICATION, RESULTING IN A CHEMOTHERAPY SPILL. THE SOLUTION WAS NOTED ON THE PATIENT'S SKIN AND CLOTHING. THE ISSUE OCCURRED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.