MalfunctionMEB
INFUSOR
Received Jul 17, 2026 · Event occurred Jun 11, 2026
Report 1416980-2026-02360 · MDR key 25855776
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2063KCatalog number
2C2063K
Lot number
25J030
Product problems
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS: (B)(6). 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 FAILED TO INFUSE DURING PATIENT USE. THE DEVICE WAS FILLED WITH FLUCLOXACILLIN 8000MG IN SODIUM CHLORIDE 0.9% (240ML TOTAL VOLUME). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.