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Received Dec 12, 2009 · Event occurred Oct 5, 2009
Report 1567114 · MDR key 1567114
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 Displays Incorrect Message
- Pressure Problem
Patient
61 YR
- No Information
Narrative
Description of Event or Problem
PATIENT ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) HAD SEVERAL INCIDENTS OF "NEGATIVE ACCESS PRESSURE" WITH PATIENT COUGHING, MOVING, ETC. RN HAD BEEN ABLE TO RELIEVE VACUUM BUILT UP AND RECOVER SEVERAL TIMES. THIS TIME SHE WAS UNABLE TO CORRECT THE ALARM AND THE MACHINE SAID "SYSTEM CLOTTED". RETURNED BLOOD AND DISCOVERED THAT THERE WAS NO CLOTTING IN THE CIRCUIT AFTER ALL. UNLOADED AND RELOADED SET, AND REPRIMED TO HOOK BACK UP TO PATIENT. PARTWAY THRU PRIME GOT "PINCH VALVE MALFUNCTION" ALARM. HAD TO UNLOAD AND RELOAD, AND RESTART MACHINE AND PRIME. ABLE TO REPRIME CIRCUIT AND HOOK BACK UP TO PATIENT, BUT PATIENT WAS OFF CRRT SEVERAL HOURS. FOUR RN'S AT BEDSIDE TROUBLESHOOTING THE SYSTEM (INCLUDED ONE CRRT ORIENTEE).