inforMED
FII

CENTRY 3, C3+

Received Mar 6, 2008 · Event occurred Sep 27, 2007

Report 1013008 · MDR key 1013008

Device

Generic name

Hemodialysis Machine

Model number

CENTRY3, C3+

Catalog number

*

Lot number

*

Product problems

  • Alarm, audible
  • Use of Device Problem
  • Device Displays Incorrect Message

Patient

8 YR

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

Narrative

Description of Event or Problem

DURING SETUP OF THE PH ALARM ON THE COBE/GAMBRO CENTRY C3+ DIALYSIS MACHINE, THE MACHINE ALARMED "DIALYSATE PH LOW." THE BIOMED TESTING CONCLUSION WAS THAT THE PROBLEM WAS DUE TO INADEQUATELY MIXED BICARB SOLUTION.