inforMED
MalfunctionFII

*

Received Dec 13, 2009 · Event occurred Nov 3, 2009

Report 1562055 · MDR key 1562055

Device

Generic name

Hemodialysis Machine, Continuous Renal Replacement Therapy

Model number

PRISMAFLEX

Catalog number

*

Lot number

*

Product problems

  • Computer Software Problem
  • Device Displays Incorrect Message

Patient

35 YR

  • No Information

Narrative

Description of Event or Problem

PATIENT WAS ON CONTINUOUS RENAL REPLACMENT THERAPY (CRRT). I PUSHED PATIENT FLUID REMOVAL FROM THE FLOW RATES SCREEN TO SET MY NEXT HOURLY RATE AND PATIENT FLUID REMOVAL HIGHLIGHTED IN RED, BUT THE RATE DID NOT. THE SCREEN WOULD NOT CHANGE FROM THIS SETUP FOR 13 MINUTES. THE ONLY BUTTON THAT WAS ABLE TO BE PUSHED WAS "ENTER", BUT THAT DID NOT HAPPEN UNTIL AFTER THE 13 MINUTES. WHEN "ENTER" WAS PUSHED AND ACTIVATED, THE STATUS SCREEN REAPPEARED. WHEN I PUSHED FLOW RATES ON THE STATUS SCREEN TO ADJUST THE PATIENT FLUID REMOVAL RATE, A MEMORY ERROR 6 OCCURRED. THE BLOOD PUMP STOPPED AND THE THERAPY WAS DISCONNECTED FROM THE PATIENT.