MalfunctionMRZ

CARTRIDGE, 3ML RG MEDICATION

Received Nov 19, 2021 · Event occurred Oct 29, 2021

Report MW5105489 · MDR key 12852005

Device

Generic name

Accessories, Pump, Infusion

Manufacturer

Chengdu Shifeng Medical Technology Co., Ltd.

Product problems

Output Problem

Patient

63 YR · Female

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

INBOUND; AFTER 48 HRS STILL HAS A LITTLE OVER 1ML AFTER VISUAL INSPECTION AT CHANGE OVER STARTED WITH 2 ML AT A RATE OF 0.042 ML/HR, CONCERNED AS THAT WOULD SEEM TO SUGGEST THAT SHE RECEIVED HALF HER MED IN THE PAST 48 HOURS. REPORT THIS IS THE THIRD TIME THIS WEEK THIS HAS HAPPENED, USING BOTH PUMPS, AND SHE PREPS HER CARTRIDGE PER USUAL PRIMING ROUTINE, WHICH MAY SUGGEST A CARTRIDGE ISSUE. NO FURTHER DETAILS PROVIDED. (B)(4).