MalfunctionMEB
INFUSOR
Received Jul 8, 2026
Report 1416980-2026-02266 · MDR key 25753127
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2009KCatalog number
2C2009K
Lot number
25N007
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE NO.: (B)(6). 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 LEAKED FROM AN UNSPECIFIED LOCATION INSIDE THE BAG. THE ISSUE WAS OBSERVED DURING DEVICE PREPARATION AND THE DEVICE WAS FILLED WITH D5W (5% DEXTROSE IN WATER). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.