AQUARIUS
Received Feb 12, 2010 · Event occurred Jan 26, 2010
Report 1614537 · MDR key 1614537
Device
Generic name
Hemodialysis System
Manufacturer
Edwards LifesciencesModel number
GEF09800Catalog 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.