inforMED
MalfunctionFII

AQUARIUS

Received Feb 12, 2010 · Event occurred Jan 26, 2010

Report 1614537 · MDR key 1614537

Device

Generic name

Hemodialysis System

Model number

GEF09800

Catalog number

*

Lot number

*

Product problems

  • Occlusion Within Device

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

AFTER STARTING THE HEMODIALYSIS SYSTEM, THE DEGASSING ALARM SOUNDED, AND TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL IN RESOLVING THE PROBLEM. THE NURSE RECOGNIZED THAT BLOOD WAS STARTING TO CLOT IN THE TUBING, AND RECIRCULATED THE BLOOD BACK TO THE PATIENT. THE TUBING WAS THEN REPLACED WITH NEW TUBING. THE ALARM SOUNDED AGAIN AND THE SAME PROBLEM OF BLOOD STARTING TO CLOT REOCCURRED. AT THIS POINT, THE HEMODIALYSIS MACHINE WAS CHANGED TO ANOTHER MACHINE OF THE SAME MAKE AND BRAND. HEMODIALYSIS WAS PERFORMED WITHOUT FURTHER PROBLEMS.THE MANUFACTURER'S SERVICE TECHNICIAN WAS CALLED IN TO CHECK THE AFFECTED MACHINE. THE PROBLEM COULD NOT BE DUPLICATED BY THE TECHNICIAN.