inforMED

GAMBRO, PHOENIX

Received May 12, 2008 · Event occurred Jan 19, 2008

Report 1048005 · MDR key 1048005

Device

Generic name

Dialysis Machine

Manufacturer

Gambro Inc.

Model number

PHOENIX

Catalog number

*

Lot number

*

Product problems

  • Alarm, audible
  • Device Displays Incorrect Message

Patient

12 YR

  • Therapy/non-surgical treatment/delayed/prolonged

Narrative

Description of Event or Problem

DIALYSIS MACHINE ALARMED CODES 148 (VENOUS CLAMP POSITION ERROR) AND 167 (BLOOD LEAK DETECTOR AUTO-CAL ALARM) RESULTING IN DELAY OF TREATMENT. NO HARM TO PATIENT.