SYSTEM 1000
Received Dec 7, 2012 · Event occurred Nov 1, 2012
Report 1416980-2012-06657 · MDR key 2862290
Device
Generic name
System, Hemodialysis, Access Recirculation Monitoring
Manufacturer
Baxter Healthcare - LargoCatalog number
S1000L3
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Hypoglycemia
- Dizziness
- Weight Changes
Narrative
Description of Event or Problem
A NURSE CONTACTED BAXTER (B)(4) REGARDING AN ULTRAFILTRATION- HIGH REPORT WITH A TINA HEMODIALYSIS MACHINE, WHICH OCCURRED DURING THERAPY WHILE THE PATIENT WAS CONNECTED. THE NURSE STATED THAT THE PATIENT WAS 1.5 KG LOWER THAN THE EXPECTED WEIGHT AND THE PATIENT EXPERIENCED LOW BLOOD PRESSURE AND DIZZINESS. HOWEVER, THERE WAS NO PATIENT INJURY AND MEDICAL INTERVENTION WAS NOT REQUIRED AS THE PATIENT RECOVERED WITHOUT ASSISTANCE.
Additional Manufacturer Narrative
(B)(4). THE MACHINE WAS EVALUATED AND THE REPORTED PROBLEM WAS CONFIRMED; THE CAUSE WAS IDENTIFIED AS DAMAGED VALVE OF ULTRAFILTRATION SYSTEM. DURING A VISUAL INSPECTION, IT WAS NOTED THAT ONE OF THE MACHINES VALVES WAS DAMAGED. DUE TO THE DAMAGED VALVE CONDITION, FUNCTIONAL TESTS WERE NOT PERFORMED. A DEVICE HISTORY REVIEW AND SERVICE HISTORY REVIEW WERE PERFORMED WITH NO ISSUES NOTED.
Additional Manufacturer Narrative
(B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED BY THE BAXTER FIELD SERVICE ENGINEER (FSE) AT THE CUSTOMER LOCATION. A FOLLOW-UP MDR WILL BE SUBMITTED UPON THE COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.