NI
Received Jun 26, 2026
Report 1416980-2026-02156 · MDR key 25640415
Device
Generic name
Pump, Infusion, Elastomeric
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4: UNIQUE IDENTIFIER (UDI) #: THE PRODUCT CODE (01) AND LOT NUMBER (10) ARE UNKNOWN; THEREFORE, THE UDI IS NOT AVAILABLE. E1: INITIAL REPORTER PHONE NO.: (B)(6). H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED ELASTOMERIC PUMP UNDERINFUSED DURING PATIENT INFUSION. THE DEVICE RAN FOR AT LEAST 6 HOURS LONGER THAN ITS INTENDED 46 HOUR DURATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.