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Received Dec 13, 2009 · Event occurred Nov 11, 2009
Report 1562045 · MDR key 1562045
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
- Device Alarm System
- Infusion or Flow Problem
Patient
38 YR
- No Information
Narrative
Description of Event or Problem
CONTINOUS RENAL REPLACEMENT THERAPY (CRRT) MACHINE ALARMING EFFLUENT VOLUME TOO HIGH/LOW 330CC. WHEN ATTEMPTED TO CORRECT ALARM, PROMPTED TO DISCONTINUE TREATMENT DUE TO VOLUME BEING REACHED. NO OTHER PRIOR ALARMS NOTED FOR EFFLUENT VOLUME IN PAST HOUR. BLOOD RETURNED TO PATIENT AND CURRENT SYSTEM TAKEN DOWN. UPON RETRIEVING NUMBERS FOR THE HOUR, DISCOVERED MACHINE SET FOR 550CC PATIENT FLUID REMOVAL. HOWEVER, MACHINE REMOVED 780CC OF FLUID FOR AN ADDITIONAL NET LOSS OF 230CC WITH NO ALARMS GIVEN FOR ADDITIONAL FLUID LOSS. BIOMED NOTIFIED OF MALFUNCTIONING MACHINE AND NEW MACHINE ORDERED.