NI
Received Jun 11, 2026 · Event occurred Apr 12, 2023
Report 1416980-2026-01975 · MDR key 25469434
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
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED ELASTOMERIC PUMP SET DID NOT EMPTY DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH TAZOCIN 18 G. THE ISSUE WAS DESCRIBED AS: "AFTER 24 HOURS THE DEVICE HAD NOT COMPLETELY EMPTIED." THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
D4: UNIQUE IDENTIFIER (UDI) #: THE PRODUCT CODE (01) AND LOT NUMBER (10) ARE UNKNOWN; THEREFORE, THE UDI IS NOT AVAILABLE. 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.