SYSTEM 1000 SPDS
Received Oct 26, 2006 · Event occurred Sep 1, 2006
Report 1423500-2006-01154 · MDR key 781056
Device
Generic name
System 1000
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
NA
Lot number
NA
Product problems
- Repair
- Underdelivery
- Wrinkled
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ON SEPTEMBER 26, 2006, THE FACILITY CONTACTED BAXTER TECHNICAL SERVICE TO REPORT A SYSTEM 1000 HEMODIALYSIS INSTRUMENT HAD PULLED 1KG OF ADDITIONAL ULTRAFILTRATE FROM A PATIENT DURING TREATMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED IN ASSOCIATION WITH THIS INCIDENT. A BAXTER FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO EVALUATE THE INSTRUMENT. THE FSE REMOVED THE UF DIAPHRAGM AND FOUND IT WAS CREASED. THE FSE THEN REPLACED THE DIAPHRAGM USING A CUSTOMER PART. THE INSTRUMENT WAS OPERATIONAL AND WITHIN MANUFACTURER'S SPECIFICATIONS. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
Additional Manufacturer Narrative
H.6 RESULTS: UF REMOVAL DIAPHRAGM FOUND CREASED.