CARTRIDGE 3ML RG MEDICATION
Received Oct 29, 2021 · Event occurred Oct 10, 2021
Report MW5105050 · MDR key 12728533
Device
Generic name
Accessories, Pump, Infusion
Lot number
10210408
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Improper Flow or Infusion
Patient
84 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
INBOUND. PATIENT REPORTED THAT AFTER SWITCHING TO GENERIC REMODULIN AND CARTRIDGES, THE PUMP KEEPS STOPPING EARLY AND DOES NOT LAST 3 DAYS. STATED WHEN REMOVING CARTRIDGE, 1 ML OF REMODULIN IS LEFT WHEN THE PUMP HAS LESS THAT 0.1 ML DISPLAYED, PATIENT STATED CURRENT PUMP SERIAL NUMBER (B)(4) - WAS STARTED AT 1900 LAST EVENING. PATIENT STATED SHE FILLED CARTRIDGE WITH 2.4 ML, BUT PUMP DISPLAYED RESERVOIR VOLUME WAS 1,047, STATED THIS MORNING AT 1030, THE RESERVOIR VOLUME WAS 0.599 MILLILITERS WITH PUMP RATE 0.028 ML PER HOUR. LOT NUMBER OF CARTRIDGE WAS 10210408. PATIENT STATED THE PLUNGER WAS STIFF DOWN BEFORE. NO FURTHER DETAILS PROVIDED.