INFUSOR
Received Jun 19, 2026 · Event occurred May 19, 2026
Report 1416980-2026-02111 · MDR key 25568085
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C1008KCatalog number
2C1008K
Lot number
24K003
Product problems
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME INFUSOR DID NOT FLOW DURING INFUSION. THE DEVICE HAD BEEN FILLED WITH FLUOROURACIL IN SALINE SOLUTION. THE DEVICE HAD A FILL VOLUME OF 240ML; AT THE END OF THE EXPECTED THERAPY TIME, 230ML OF SOLUTION REMAINED IN THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.