RATE-FLOW
Received Oct 16, 2018
Report 9611707-2018-00043 · MDR key 7969265
Device
Generic name
Intravascular Administration Set
Manufacturer
Leventon S.a.u.Model number
US5300Catalog number
L2590260-US5300
Lot number
UNK.
Product problems
- Excess Flow or Over-Infusion
- Excess Flow or Over-Infusion
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT HAS BEEN RECORDED IN LEVENTON S.A.U. AS A CUSTOMER COMPLAINT (B)(4). THE DEFECTIVE UNIT WAS NOT RETURNED TO THE MANUFACTURER, THUS THE DEVICE WAS NOT EVALUATED. IN ADDITION, THE LOT NUMBER IS UNKNOWN. THEREFORE, THE DEFECT REPORTED BY THE CUSTOMER COULD NOT BE REPRODUCED. ANYWAY, NOTHING JUSTIFIES THE OCCURRENCE OF SUCH AN INCIDENCE. THE POSITION OF 250 ML/H IS THE MAXIMUM VALUE OF THE SCALE OF THE FLOW REGULATOR. THEN, IF THE DIRECTIONS FOR SETTING UP THE PRODUCT ACCORDING TO THE IFU ARE FOLLOWED, IT IS NOT POSSIBLE TO GET THE DOUBLE OF FLOWRATE IN THIS POSITION.
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: EVENT 3. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR; WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.