MICRO-VOLUME EXTENSION SET
Received Sep 10, 2024 · Event occurred Aug 15, 2024
Report 1416980-2024-04869 · MDR key 20180310
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter International Inc.Model number
2N3350Catalog number
2N3350
Lot number
NI
Product problems
- Backflow
- Backflow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 A MICRO-VOLUME EXTENSION SET HAD LIPIDS BACKING UP IN THE TUBING. THE BACKFLOW WAS CAUSING THE OCCLUSION LIMIT TO GO OFF ON THE PUMP. THIS OCCURRED DURING INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.