MalfunctionMEB
INFUSOR
Received Jun 26, 2026
Report 1416980-2026-02167 · MDR key 25642886
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
J2C1711Catalog number
J2C1711
Lot number
25J004
Product problems
- Material Rupture
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 THE BLADDER OF A SMALL VOLUME INFUSOR RUPTURED AND LEAKAGE OF THE DRUG SOLUTION WAS NOTED INTO THE HOUSING. THE ISSUE OCCURRED AFTER THE DEVICE WAS FILLED WITH DRUG SOLUTION IN THE PHARMACY DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.