inforMED
OtherFII

PHOENIX

Received Jun 23, 2008 · Event occurred May 13, 2008

Report 2087532-2008-00056 · MDR key 1076182

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

UNKNOWN

  • Death

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT A PT EXPIRED WHILE DIALYZING ON A PHOENIX MACHINE, SOFTWARE VERSION 3.34. FACILITY NURSE MGR REFUSED TO PROVIDE ANY ADD'L INFO INCLUDING THE DISPOSABLES THAT WERE USED. SHE STATED THAT IT WAS A VIOLATION OF DCI'S POLICY TO DIVULGE ANY PT INFO.