MalfunctionMRZ

RG 3ML CARTRIDGE

Received Nov 9, 2021 · Event occurred Oct 20, 2021

Report MW5105245 · MDR key 12787772

Device

Generic name

Accessories, Pump, Infusion

Manufacturer

Chengdu Shifeng Medical Technology Co., Ltd.

Lot number

210408

Product problems

Infusion or Flow Problem
Output Problem

Patient

63 YR · Female

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

INBOUND. PATIENT REPORTED SHE HAS MORE TREPROSTINIL LEFT IN CADD MS3 RG SYRINGES THEN PUMP IS SHOWING, AND PUMP LOW CARTRIDGE ALERT IS STARTING ANYWHERE FROM 1 HOUR TO 1 DAY TOO EARLY. CARTRIDGE LOT 210408. NO FURTHER DETAILS PROVIDED.