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OtherFII

PHOENIX

Received Sep 10, 2008 · Event occurred Aug 4, 2008

Report 2087532-2008-00095 · MDR key 1238783

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Product code (FII)
Manufacturer (Gambro Dasco S.p.a., Monitors Division)
Model (PHOENIX)

Device

Generic name

Hemodialysis Equipment

Manufacturer

Gambro Dasco

Model number

PHOENIX

Catalog 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.