inforMED
MalfunctionFII

*

Received Dec 13, 2009 · Event occurred Nov 7, 2009

Report 1562051 · MDR key 1562051

Device

Generic name

Hemodialysis, Continuous Renal Replacement Therapy

Model number

PRISMAFLEX

Catalog number

*

Lot number

*

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.