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Received Dec 13, 2009 · Event occurred Nov 3, 2009
Report 1562055 · MDR key 1562055
Device
Generic name
Hemodialysis Machine, Continuous Renal Replacement Therapy
Manufacturer
Gambro Renal Products, Inc.Model number
PRISMAFLEXCatalog number
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Lot number
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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.