RATE-FLOW
Received Oct 16, 2018 · Event occurred Aug 25, 2018
Report 9611707-2018-00044 · MDR key 7969259
Device
Generic name
Intravascular Administration Set
Manufacturer
Leventon S.a.u.Model number
US5300Catalog number
L2590260-US5300
Lot number
180946L
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 (B)(4) AS A CUSTOMER COMPLAINT ((B)(4)). THE DEFECTIVE UNIT WAS NOT RETURNED TO THE MANUFACTURER, THUS THE DEVICE WAS NOT EVALUATED. SIX (6) UNITS FROM THE SAME MANUFACTURING LOT WERE RETRIEVED FROM RETAINED SAMPLES AND SUCCESSFULLY PASSED FLOW RATE STABILITY TEST AND FLOW RATE ACCURACY TEST. IN ADDITION, THE BATCH RECORD OF THE AFFECTED LOT NUMBER WAS REVIEWED AND NO INCIDENCE SIMILAR TO THE ONE REPORTED WAS DETECTED IN THE CONTROLS DONE DURING THE MANUFACTURING PROCESS NOR IN THE CONTROLS DONE BEFORE THE PRODUCT RELEASE. 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 USER FACILITY: EVENT 1. 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.