GAMBRO

Description of Event or Problem

CONTINUOUS DIALYSIS WAS INITIATED ON (B)(6) 2011. INITIAL SET-UP OF THE GAMBRO PRISMA CRRT MACHINE WAS UNEVENTFUL. DURING THERAPY FROM (B)(6) 2011 THROUGH (B)(6) 2012, THE MACHINE HAD MULTIPLE SELF-TEST FAILURES, BUT WERE RESOLVED WITH HELP THROUGH PHONE CALLS TO TECHNICAL SUPPORT. THE TWO FAILURE CODES WERE 00C0-FILTER AND EFFLUENT POD AND 0040-FILTER PRESSURE POD. AFTER SEVERAL DAYS OF INTERRUPTED THERAPY, A SECOND MACHINE WAS BROUGHT IN, PRIMED, AND THERAPY RESTARTED ON (B)(6) 2012. THE ERROR CODES CONTINUED TO OCCUR AND TECHNICAL SUPPORT CONTINUED TO PROVIDE GUIDANCE, WHICH APPEARED TO RESOLVE THE ERRORS. AT APPROXIMATELY 12:30 ON (B)(6) 2012, THE PATIENT WAS UNRESPONSIVE IN PEA. WE ARE UNABLE TO DETERMINE AT THIS TIME WHETHER THE MACHINE MALFUNCTION CONTRIBUTED TO THE PATIENT'S DEATH, AS THE PATIENT HAD A COMPLEX MEDICAL HISTORY.

Additional Manufacturer Narrative

AT THIS TIME IT IS UNCLEAR WHETHER THE DEVICE ERRORS ARE RELATED TO THE PATIENT DEATH, BUT BECAUSE WE CANNOT RULE THIS OUT, ARE REPORTING SAME. IN RESPONSE TO SECTION F, THERE WERE TWO DEVICES THAT CONTAINED THE SAME ERRORS. BECAUSE THE MANUFACTURER RETRIEVED THESE DEVICES BEFORE WE COULD COMPLETE REPORTING, WE DO NOT HAVE INFORMATION AS TO WHICH DEVICE WAS BEING UTILIZED AT THE TIME OF THE PATIENT'S DEATH, AND HAVE THUS, INCLUDED SERIAL NUMBERS FOR BOTH.