SYSTEM 1000
Received Nov 1, 2012 · Event occurred Oct 4, 2012
Report 1416980-2012-03218 · MDR key 2814191
Device
Generic name
System, Hemodialysis, Access Recirculation Monitoring
Manufacturer
Baxter Healthcare - LargoCatalog number
S1000L3P
Product problems
- Device Emits Odor
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING A BURNT ODOR COMING FROM A TINA HEMODIALYSIS MACHINE, DURING CITRIC HEAT CLEAN, WHILE THE HOME PATIENT (HP) WAS NOT CONNECTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.
Additional Manufacturer Narrative
(B)(4). THIS COMPLAINT FOR A REPORT OF "BURNT ODOR" WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A BLOCKAGE OF AIR INLET BECAUSE OF DUST ACCUMULATION. NO SAMPLE WAS RETURNED FOR EVALUATION AS THE DEVICE WAS EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) AT THE CUSTOMER LOCATION. DURING THE EVALUATION, THE REPORTED CONDITION OF: "SMELLING BURNING SMELL" WAS CONFIRMED BUT NOT DUPLICATED BY THE FSE. VISUAL INSPECTION WAS PERFORMED AND NO ISSUES WERE OBSERVED. AS PART OF CORRECTIVE ACTION FOR REPORTED PROBLEM; THE FSE CLEARED ALL OF THE DUST IN THE FAN INPUT GRILLS (INTERNAL FILTER WAS CHECKED AND WAS FOUND TO BE CLEAN) AND PERFORMED SELF TEST. THE DEVICE WAS EVALUATED AND ALL NECESSARY FUNCTIONAL TESTS WERE PERFORMED AND PASSED AS PER BAXTER?S STANDARD OPERATING POLICIES AND PROCEDURES.