MalfunctionMEB
INFUSOR
Received Jun 25, 2026
Report 1416980-2026-02135 · MDR key 25621403
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C9960KPCatalog number
2C9960KP
Lot number
25C016
Product problems
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A LARGE VOLUME MULTIRATE INFUSOR LEAKED AT THE FLOW REGULATOR SITE. THIS OCCURRED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.