inforMED
MalfunctionFII

GAMBRO

Received Nov 24, 2010 · Event occurred Aug 18, 2010

Report MW5018365 · MDR key 1916775

Device

Generic name

Phoenix Dialysis Machine

Lot number

GE35806352

Product problems

  • Device Displays Incorrect Message
  • Calibration Problem

Patient

Not reported

  • No Information

Narrative

Description of Event or Problem

MACHINE DID NOT COME UP TO CONDUTIVITY; MULTIPLE ALARM CODES; AUTOCALIBRATION FAILED; CONCENTRATE TYPE ERROR #40; RECALIBRATED MACHINE FOR BRIEF PERIOD THEN MACHINE STARTED TO ALARM AGAIN.