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PHOENIX

Received Jan 31, 2008 · Event occurred Jan 2, 2008

Report 2087532-2008-00009 · MDR key 996271

Device

Generic name

Hemodialysis Equipment

Manufacturer

Gambro Dasco

Model number

PHOENIX

Catalog number

6023006700

Lot number

NA

Product problems

  • Normal
  • Unknown (for use when the device problem is not known)

Patient

60 YR

  • Cardiopulmonary Arrest
  • Death

Narrative

Description of Event or Problem

A CLINIC REPORTED THAT A PT HAD BEEN ON A PHOENIX MACHINE FOR APPROX THREE TO FOUR MINS WHEN THE PT ASKED TO BE TAKEN OFF THE MACHINE TO GO TO THE BATHROOM. THE PT CODED ON THE WAY TO THE BATHROOM AND COULD NOT BE RESUSCITATED. THE FACILITY'S NURSE MGR DOES NOT FEEL THAT THE PHOENIX MACHINE CAUSED OR CONTRIBUTED TO THIS PT'S DEATH. A GTS REP INSPECTED THE MACHINE AND FOUND THAT THE MACHINE PERFORMED ACCORDING TO MFR'S SPECS. THE MACHINE IS BACK IN SVC.