LEVELERT II FLUID LEVEL SENSOR
Received Jan 17, 2017 · Event occurred Dec 7, 2016
Report 1643264-2017-00038 · MDR key 6255700
Device
Generic name
Monitor, Electric For Gravity Flow Infusion Systems
Manufacturer
Smith & Nephew, Inc.Catalog number
7211011
Product problems
- Failure to Sense
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
COMPLAINT OF ALARM MALFUNCTION COULD NOT BE CONFIRMED. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE FUNCTIONAL TESTING PROCESS. PRODUCT PASSED FUNCTIONAL TESTING AND ALARM FUNCTION PERFORMED AS EXPECTED. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. NO PROBLEM FOUND.
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
IT WAS REPORTED THE LEVELERT II FLUID LEVEL SENSOR DOESN'T ALARM WHEN THE FLUID BAG IS AT THE DESIRED ALARM LEVEL. NO BACKUP DEVICE AVAILABLE. PROCEDURE COMPLETED WITHOUT A FLUID MANAGEMENT DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.