RG 3ML CARTRIDGE
Received Nov 9, 2021 · Event occurred Sep 20, 2021
Report MW5105246 · MDR key 12787789
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Chengdu Shifeng Medical Technology Co., Ltd.Product problems
- Complete Blockage
- Device Displays Incorrect Message
Patient
72 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
OUTBOUND CALL, PT'S WIFE, REPORTS PT STILL GETS ERROR MESSAGES FROM HIS PUMP THAT A BLOCKAGE IS DETECTED. PUMP SN (B)(4), WIFE REPORTS IT HASN'T HAPPENED WITH HIS LAST 2 CARTRIDGE CHANGES BUT DEFINITELY HAS OCCURRED. RECENTLY, SHE NOTED IT NEVER OCCURS WITH THE CADD MS3 CARTRIDGES. IT ONLY OCCURS WITH THE RG 3ML CARTRIDGES. WIFE REPORTS SHE HAS USED THE CADD MS3 CARTRIDGES WITH THE GENERIC TREPROSTINIL, I RECOMMENDED NOT DOING THAT AND TO ONLY USE THE CADD MS3 CARTRIDGES WITH BRAND REMODULIN AND USE REG CARTRIDGES WITH THE GENERIC TREPROSTINIL. WIFE REPORTS SHE TRIES TO LUBRICATE THE CARTRIDGE BY MOVING THE SYRINGE ROD UP AND DOWN BEFORE USE. REPLACEMENT PUMPS SENT WITH BOX FOR RETURN. NO FURTHER DETAILS PROVIDED.