PHOENIX
Received Sep 10, 2008 · Event occurred Aug 4, 2008
Report 2087532-2008-00095 · MDR key 1238783
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Leak/Splash
- Output, low
Patient
57 YR
- No Consequences Or Impact To Patient
- Malaise
- Weight Changes
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT A PHOENIX MACHINE, SERIAL NUMBER, SOFTWARE VERSION 3.34, REMOVED THREE KG OF EXCESS FLUID ON A PT. THERE WAS NO INJURY, MEDICAL INTERVENTION OR BLOOD LOSS REPORTED. ACCORDING TO FACILITY BIOMEDICAL TECH, ABOUT 10 MINUTES BEFORE THE PT WAS TO COME OFF OF DIALYSIS, SHE STARTED COMPLAINING OF "NOT FEELING WELL". HER BLOOD PRESSURE REMAINED NORMAL WITHOUT ANY SIGNS OR SYMPTOMS OF HYPOTENSION. WHEN THE PT WAS WEIGHED BEFORE LEAVING THE CLINIC, HOWEVER, SHE WAS SIX KG LIGHTER INSTEAD OF THE THREE THAT HAD BEEN PROGRAMMED. ACCORDING TO FACILITY BIOMEDICAL TECH, THIS PT IS A SELF-WEIGH AND FREQUENTLY COMES INTO THE DIALYSIS CLINIC EIGHT TO NINE KILOGRAMS OVER HER DRY WEIGHT OF 86.8 KG. THIS WOULD EXPLAIN THE ABSENCE OF HYPOTENSIVE SYMPTOMS AS THE PT'S BLOOD PRESSURE REPORTEDLY REMAINED CONSISTENT THROUGHOUT THE ENTIRE DIALYSIS RUN. THERE WERE NO ALARMS DURING THE TREATMENT THAT WOULD'VE ALERTED THE STAFF THAT THE MACHINE WAS REMOVING AN INACCURATE AMOUNT OF FLUID.