MalfunctionFII
GAMBRO DIALYSIS MACHINE
Received May 12, 2008 · Event occurred May 7, 2007
Report 1055944 · MDR key 1055944
Device
Generic name
Hemodialysis System
Manufacturer
Gambro Renal Products, Inc.Model number
PHOENIXCatalog number
*
Lot number
*
Product problems
- Alarm, audible
Patient
19 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE MACHINE HAD TWO ALARMS; THE PROTECTIVE CARD COMMUNICATION TIMEOUT ALARM AND THE BLOOD CARD COMMUNICATION TIMEOUT. THESE ALARMS WERE FOLLOWED BY A GENERAL SAFE STATE ALARM THAT WOULD ONLY ALLOW THE OPERATOR TO POWER THE MACHINE DOWN AND RESTART THE TREATMENT. AFTER THE PROCEDURE WAS RESTARTED, THE DIALYSIS MACHINE AGAIN EXPERIENCED THE SAME ALARM SEQUENCE.