MalfunctionFII

PHOENIX

Received Jun 17, 2008 · Event occurred Dec 7, 2007

Report 1064843 · MDR key 1064843

Device

Generic name

Hemodialysis Machine

Manufacturer

Gambro Renal Products, Inc.

Model number

Catalog number

Lot number

Product problems

Alarm, audible
Design/structure problem
Repair

Patient

14 YR

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

Narrative

Description of Event or Problem

PATIENT RECEIVING DIALYSIS TREATMENT FOR 30 MINUTES WHEN D1 AND D2 ALARMS KEPT APPEARING WHICH PROMPTED THE NURSE TO RETURN THE BLOOD AND CHANGE MACHINES.