MalfunctionMRZ
CARTRIDGE, 3ML RG MEDICATION
Received Mar 21, 2022 · Event occurred Feb 17, 2022
Report MW5108355 · MDR key 13845985
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Chengdu Shifeng Medical Technology Co.,ltdProduct problems
- Display or Visual Feedback Problem
- Device Displays Incorrect Message
Patient
84 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
OUTBOUND. PATIENT AND HUSBAND REPORT CADD MS3 PUMP ALARMING LOW VOLUME EARLIER THAN PROGRAMMED AND YESTERDAY, AFTER CONTINUING THE INFUSION AND RESTARTING PUMP, THE PUMP DISPLAYED ZERO. ACTUAL AMOUNT OF MEDICATION IN THE CARTRIDGE WAS 0.3 ML BUT THIS OCCURS WITH BOTH PUMPS. HUSBAND DESCRIBED THE CARTRIDGES AS HARD TO PULL THE PLUNGER AND HAS TO PUSH AND PULL SEVERAL TIMES TO TRY TO LUBRICATE THE BARREL. PUMP SN# (B)(4) NO CASSETTE LOT NUMBER PROVIDED. DID NOT NEED PUMP REPLACEMENTS. NO FURTHER DETAILS PROVIDED. WHELE LLC.