inforMED
MalfunctionBTC

WALKMED®

Received Oct 3, 2017 · Event occurred Sep 7, 2017

Report 6910225 · MDR key 6910225

Device

Generic name

Bag, Reservoir

Model number

204821

Catalog number

IPR-150

Product problems

  • Leak/Splash

Patient

52 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

PATIENT DID NOT ACTUALLY RECEIVE MEDICATION DUE TO ADVERSE DRUG EVENT FROM ANOTHER MEDICATION. THIS PATIENT'S FLUOROURACIL (5-FU) BAG WAS MADE AND STORED FOR FUTURE USE. UPON INSPECTION IN STORAGE IT WAS DISCOVERED THAT IT HAD LEAKED. NO PATIENT HARM. PATIENT CAME TO CLINIC FOR 5-FU DISCONNECT AND IVF. WHEN PUMP EXAMINED CRYSTALLIZATION NOTED AROUND PUMP AND ON POUCH. THE 5-FU WAS DISCONNECTED WITH 2 ML REMAINING. NO PATIENT HARM. PHARMACIST REPORTED THAT PATIENT'S FLUOROURACIL INFUSION BAG WAS LEAKING AND HAD TO BE REPLACED. NO PATIENT HARM.