inforMED
MalfunctionMRZ

CARTRIDGE, 3ML RG MEDICATION

Received Nov 19, 2021 · Event occurred Nov 1, 2021

Report MW5105488 · MDR key 12851998

Device

Generic name

Accessories, Pump, Infusion

Lot number

450533

Product problems

  • Infusion or Flow Problem

Patient

69 YR · Female

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

REPORTS ALSO SINCE SHE WAS SWITCHED TO TREPROSTINIL PUMP WITH NEW SYRINGES, HAVING ISSUES WITH SYRINGE NOT LASTING 24 HOURS YET WHEN SHE TAKES IT OUT OF THE PUMP THERE IS STILL A MILLILITER OF DRUG LEFT IN SYRINGE. STATES SHE IS WASTING A LOT OF DRUG BECAUSE OF THIS. SHE LUBRICATES THE SYRINGE AS SHE HAS BEEN INSTRUCTED TO BUT SAYS IT NEVER GETS ANY EASIER TO PUSH AND PULL THE PLUNGER. IT IS EXTREMELY DIFFICULT. SENDING REPLACEMENT PUMPS, SO PT CAN SEND THEM BACK TO ACCREDO WITH SYRINGE INSTALLED WHEN THIS OCCURS AGAIN. PT HAS CADD MS3 PUMP SERIAL NUMBERS (B)(4) AND (B)(4). NO FURTHER DETAILS PROVIDED. (B)(4).