CARTRIDGE 3ML RG MEDICATION
Received Oct 29, 2021 · Event occurred Oct 19, 2021
Report MW5105047 · MDR key 12728491
Device
Generic name
Accessories, Pump, Infusion
Lot number
10210408
Product problems
- False Alarm
Patient
51 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
INBOUND; PT REPORTS TREPROSTINIL MS3 SYRINGES ALARM LOW VOLUME 2 TO 3 HRS EARLIER THAN EXPECTED AND HAS HAD ONGOING ISSUE WITH THIS SINCE CHANGING TO TREPROSTINIL. PT REPORTS THIS HAPPENING AGAIN TODAY AND HAD PLANNED ON SENDING CADD MS3 PUMP SERIAL NUMBER (B)(4) BACK WITH AN AFFECTED SYRINGE PER REQUEST, BUT THE SYRINGE CAP ON BACKUP PUMP BROKE AND HAD TO TAKE THE SYRINGE CAP OFF THE AFFECTED PUMP. REPORTS WILL NOTIFY (B)(6). THE NEXT TIME THIS HAPPENS AND SEND BACK A PUMP WITH A SYRINGE LOADED IN PLACE. SYRINGE LOT NUMBER 1020408 REPORTED. PT ALSO COMPLAINS OF THE PROSTINIL CARTRIDGES ARE HARD TO PUSH PLUNGER AND "THE MEDICATION HAS TO CHANGE 2 HRS EARLY EVERYTIME" 10210408. NO FURTHER DETAILS PROVIDED. (B)(6).