inforMED
MalfunctionFII

*

Received Dec 12, 2009 · Event occurred Oct 5, 2009

Report 1567114 · MDR key 1567114

Device

Generic name

Hemodialysis Machine, Continuous Renal Replacement Therapy

Model number

PRISMAFLEX

Catalog number

*

Lot number

*

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).