INFUSOR
Received Jun 25, 2026 · Event occurred May 28, 2026
Report 1416980-2026-02143 · MDR key 25631418
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
2C2063KCatalog number
2C2063K
Lot number
25K031
Product problems
- Fluid/Blood Leak
Patient
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 LEAKED INTO THE SEALED OVERPOUCH. THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THE DEVICE WAS FILLED WITH 18000MG PIPERACILLIN / TAZOBACTAM AND 0.9% SODIUM CHLORIDE HAVING A TOTAL VOLUME OF 240ML. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.