MalfunctionMRZ
CARTRIDGE 3ML RG MEDICATION
Received Oct 29, 2021 · Event occurred Oct 21, 2021
Report MW5105043 · MDR key 12728420
Device
Generic name
Accessories, Pump, Infusion
Lot number
210408
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
63 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
INBOUND; PT REPORTS DRAWING UP 2.8 ML OF TREPROSTINIL IN SYRINGE AND AFTER LOADING, FILLING TUBING AND STARTING INFUSION, THE PUMP DISPLAYS HER ONLY HAVING 1.5 ML LEFT, WHICH WILL NOT LAST HER 72 HOURS. HER SYRINGE ACTUALLY HAS 2.6 MLS IN IT BUT SINCE THE PUMP CANNOT READ THAT, IT WILL THINK IT IS EMPTY SOONER. ASSISTED PT WITH RELOADING THE SYRINGE AND NO CHANGE IN VOLUME. PRIOR TO DRAWING UP DRUG, PT LUBRICATES THE SYRINGE BY PUSHING AND PULLING THE PLUNGER, TWELVE TIMES. THE LOT NUMBER FOR SYRINGE IS 210408, EXP: 4/7/2026. NO FURTHER DETAILS PROVIDED. WHELE LLC.