SYSTEM 1000
Received Aug 7, 2012 · Event occurred Jul 16, 2012
Report 1423500-2012-15628 · MDR key 2684191
Device
Generic name
System, Hemodialysis, Access Recirculation Monitoring
Manufacturer
Baxter Healthcare - LargoCatalog number
S1000L3P
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). NO SAMPLE WAS RETURNED FOR EVALUATION AS THE DEVICE WAS EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) AT THE CUSTOMER LOCATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
(B)(4). THIS COMPLAINT FOR A ULTRAFILTRATION-LOW REPORT WAS CONFIRMED DURING THE ON-SITE SAMPLE EVALUATION AND THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A DAMAGED ULTRAFILTRATION (UF) REGULATOR. THE UF REGULATOR WAS REPLACED WITH A NEW ONE. A DEVICE HISTORY WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE ULTRAFILTRATION- LOW IN THE LOGS DURING THE MANUFACTURE OF THE LOT OR SERIAL NUMBER. A SERVICE HISTORY REVIEW WAS PERFORMED WITH NO ISSUES NOTED.
Description of Event or Problem
A NURSE CONTACTED BAXTER (B)(4) REGARDING AN ULTRAFILTRATION LOW THAT HAPPENED WITH A TINA HEMODIALYSIS MACHINE. THE NURSE STATED THAT THE TINA MACHINE DID NOT ULTRAFILTRATE THE 3.3 KILOGRAMS THAT WAS PROGRAMMED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.