SYSTEM 1000
Received Jan 9, 2013 · Event occurred Nov 1, 2012
Report 1416980-2013-00601 · MDR key 2903859
Device
Generic name
System, Hemodialysis, Access Recirculation Monitoring
Manufacturer
Baxter Healthcare - LargoCatalog number
S1000L3
Product problems
- Loose or Intermittent Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A NURSE CONTACTED BAXTER (B)(4) REGARDING AN INCIDENT OF AN ULTRAFILTRATION ISSUE ON A TINA HEMODIALYSIS MACHINE, DURING USE. THE NURSE STATED THAT THE PATIENT HAD A LOSS OF 1.5KG AFTER TREATMENT AND THE MACHINE WAS PROGRAMMED WITH 2.5KG. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Additional Manufacturer Narrative
(B)(4). THE DEVICE IS 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.
Additional Manufacturer Narrative
(B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.
Additional Manufacturer Narrative
(B)(4). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONAL TESTS WERE PERFORMED AND THE RESTRICTED FLOW WAS CONFIRMED, DUE TO A DIENER PUMP FAILURE. THE FAULTY PUMP WAS CHANGED, AND THE NEW DIENIER PUMP PASSED ALL TESTS. A DEVICE HISTORY LOG REVIEW AND SERVICE HISTORY REVIEW WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM; AND THE ROOT CAUSE WAS DETERMINED TO BE A FAULTY DIENIER PUMP.