MalfunctionMEB
INFUSOR
Received Jun 25, 2026 · Event occurred May 14, 2026
Report 1416980-2026-02133 · MDR key 25620515
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2009KCatalog number
2C2009K
Lot number
26A010
Product problems
- Filling Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME INFUSOR OVER INFUSED DURING INFUSION. THE DEVICE WAS EXPECTED AND INTENDED TO INFUSE OVER 46 HOURS; HOWEVER, THE ACTUAL INFUSION TIME WAS 22 HOURS (24 HOURS EARLIER THAN EXPECTED). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE NO - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.