INFUSOR
Received Jul 1, 2026 · Event occurred May 30, 2026
Report 1416980-2026-02203 · MDR key 25678120
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2009KCatalog number
2C2009K
Lot number
25G022
Product problems
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS - (B)(6) HOSPITAL . E1: INITIAL REPORTER POSTAL CODE - SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME INFUSOR WAS LEAKING FROM AN UNSPECIFIED LOCATION. IT WAS OBSERVED THAT THE FLUOROURACIL INFUSOR WAS LEAKING CHEMOTHERAPY INTO THE BOTTLE FROM AN UNSPECIFIED LOCATION. THE DEVICE WAS FILLED WITH FLUOROURACIL HS (ACCORD) 4025MG IN SODIUM CHLORIDE 0.9% 230ML TOTAL VOLUME. THIS ISSUE WAS OBSERVED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.