inforMED
OtherFII

PHOENIX

Received Sep 18, 2008 · Event occurred Aug 12, 2008

Report 2087532-2008-00098 · MDR key 1163283

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 AN ADULT FEMALE PT EXPIRED ABOUT 1 1/2 HRS INTO THEIR HEMODIALYSIS TREATMENT. A GAMBRO SVC TECH INSPECTED THE MACHINE PRIOR TO ITS RETURN TO CLINICAL USE. IT IS THE DCI CORPORATE POLICY THAT NO OTHER INFO ABOUT THE PT OR THE TREATMENT WILL BE DISCLOSED.