MalfunctionFII
CRRT MACHINE
Received Dec 20, 2010 · Event occurred Nov 30, 2010
Report 1941545 · MDR key 1941545
Device
Generic name
Crrt Machine
Manufacturer
Gambro Renal Products, Inc.Model number
PRISMAFLEXCatalog number
NOT APPLICABLE
Lot number
NOT APPLICABLE
Product problems
- Device Alarm System
- Application Interface Becomes Non-Functional Or Program Exits Abnormally
Patient
65 YR
- No Information
Narrative
Description of Event or Problem
THE HEALTHCARE PRACTITIONER ENTERED THE ROOM TO RETRIEVE THE PREVIOUS HOURS ULTRAFILTRATION READING AND ALL OF THE SOFT KEYS LOCKED UP AND WOULD NOT WORK. IMMEDIATELY FOLLOWING, THE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) MACHINE ALARMED AND STATED MALFUNCTION (SIX). IT WOULD NOT ALLOW THE PRACTITIONER TO OVERRIDE THE ALARM. AN ATTEMPT WAS MADE TO GIVE THE BLOOD BACK TO THE PATIENT. DOWNLOADED DATA AND SHUT OFF THE MACHINE.