MalfunctionMRZ
CARTRIDGE, 3ML RG MEDICATION
Received Jan 7, 2022 · Event occurred Dec 22, 2021
Report MW5106539 · MDR key 13206923
Device
Generic name
Accessories, Pump, Infusion
Lot number
210720
Product problems
- Inaccurate Flow Rate
Patient
54 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INBOUND; PT REPORTED SIX TREPROSTINIL CARTRIDGES OUT OF THE LAST EIGHT HAVE STOPPED EARLY WITH PUMP ALARMING LOW VOLUME BY 4 HRS EACH TIME, THE PT STATED FILLING WITH 3 MILLILITERS TO LAST 48 HRS AT RATE OF 0.05 MILLILITERS PER HOUR, LOT NUMBER 210720. STATED PUMP SERIAL NUMBER IS (B)(4). NO FURTHER DETAILS PROVIDED.