OtherFII
SYSTEM 1000 SPDS
Received Oct 5, 2006 · Event occurred Sep 5, 2006
Report 1423500-2006-01098 · MDR key 808658
Device
Generic name
System 1000
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
NA
Lot number
NA
Product problems
- Replace
- Inadequate Ultra Filtration
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ON SEPTEMBER 5, 2006, THE FACILITY CONTACTED BAXTER CUSTOMER SERVICE TO REPORT AFTER AN HOUR OF TREATMENT OF A SYSTEM 1000 HEMODIALYSIS INSTRUMENT, THE ULTRAFILTRATION REMOVED SHOWED 10.6, AND THE ULTRAFILTRATION GOAL HAD BEEN REACHED. THE PATIENT WAS MOVED TO ANOTHER MACHINE AND CONTINUED TREATMENT. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EFFECTS FROM THIS INCIDENT. THE CUSTOMER WAS INSTRUCTED TO SWAP THE UF CONTROLLER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.