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Received Dec 13, 2009 · Event occurred Nov 7, 2009
Report 1562051 · MDR key 1562051
Device
Generic name
Hemodialysis, 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
- Issue With Displayed Error Message
Patient
26 YR
- No Information
Narrative
Description of Event or Problem
CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) MACHINE ALARMED CONTINUOUSLY FOR HIGH NEGATIVE PRESSURE , NO ACCESS DETECTED, AND LINE DISCONNECT WHEN NONE OF THESE EVENTS WERE HAPPENING. PRESSURE WAS -75, WHICH SHOULD HAVE BEEN ACCEPTABLE. HELP LINE INDICATED THAT RANGE WAS INAPPROPRIATE, AND DIRECTED CLINICIAN TO GO TO RECIRC MENU. THERE WAS NO OPTION IN THAT MENU TO CHANGE RANGE, AND THERE WAS NO OPTION TO RESUME THERAPY. HAD TO FLUSH, THEN DISCONNECT, AND THEN RECIRC PATIENT. THE MACHINE WOULD NOT LET US PRIME AND RESTART THERAPY, AND CONTINUALLY ALARMED BLOOD IN LINE. NO BLOOD PATH SEEN. THREE RN'S TRIED TO TROUBLESHOOT. EVENTUALLY, WE STOPPED AND SET UP NEW FILTER DESPITE THE FACT THERE WERE NO CLOTS, ETC. UNABLE TO REMOVE MACHINE AS NO REPLACEMENT AVAILABLE. DECIDED FLAWED DEVICE BETTER THAN NO DEVICE. DEVICE STILL IN ROOM.