MalfunctionFII
SYSTEM 1000 SPDS
Received Sep 28, 2006 · Event occurred Sep 1, 2006
Report 1423500-2006-01067 · MDR key 841741
Device
Generic name
System 1000
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
NA
Lot number
NA
Product problems
- Use of Device Problem
- Microbial Contamination of Device
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IN 2006, THE FACILITY CONTACTED BAXTER CUSTOMER SERVICE TO REPORT A SYSTEM 1000 HEMODIALYSIS INSTRUMENT WAS FOUND TO HAVE A HIGH BACTERIA COUNT AFTER DISINFECT. THE BAXTER TECHNICAL SUPPORT REP EXPLAINED TO THE CUSTOMER HOW TO DISINFECT THE COMPLETE SYSTEM INCLUDING THE INCOMING WATER LINE. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED IN ASSOCIATION TO THIS INCIDENT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SENT.