MalfunctionFII

PHOENIX

Received Jun 12, 2009 · Event occurred Feb 9, 2009

Report 1405955 · MDR key 1405955

Device

Generic name

Hemodialysis Machine

Manufacturer

Gambro Renal Products, Inc.

Model number

Catalog number

Lot number

Product problems

Alarm, audible
Decrease in Pressure
Failure to Reset

Patient

12 YR

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

Narrative

Description of Event or Problem

SOON AFTER STARTING DIALYSIS THE VENUS PRESSURE STARTED TO DROP AND MACHINE GAVE ALARMS. TRIED TO RESET IT. BLOOD RETURNED TO PATIENT. RESTARTED WITH NEW SET UP, AND AGAIN THE SAME PROBLEMS NOTED.