MalfunctionFII

HEMODIALYSIS MACHINE

Received May 12, 2008 · Event occurred Aug 7, 2007

Report 1052107 · MDR key 1052107

Device

Generic name

Hemodialysis Machine

Manufacturer

Gambro

Model number

PHOENIX

Catalog number

Lot number

Product problems

Alarm, audible
Calibration Error

Patient

16 YR

Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

DURING A PATIENT TREATMENT, THE DIALYSIS MACHINE PRODUCED ALARM CODES #145 AND #73 INDICATING THAT THE ULTRA-FILTRATION VESSEL WAS OUT OF CALIBRATION.