SYSTEM 1000
Received Jul 18, 2013 · Event occurred Jun 24, 2013
Report 1416980-2013-18894 · MDR key 3234931
Device
Generic name
System, Hemodialysis, Access Recirculation Monitoring
Manufacturer
Baxter Healthcare - LargoCatalog number
S1000L3P
Product problems
- Inadequate Ultra Filtration
Patient
Not reported
- Weight Changes
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE IS BEING EVALUATED BY A FIELD SERVICE ENGINEER (FSE) AT THE CUSTOMER LOCATION. VISUAL INSPECTION WAS PERFORMED, NO PHYSICAL DAMAGE WAS FOUND. THE DEVICE PASSED ALL TESTING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
(B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED; THE CAUSE WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD HIGH ULTRAFILTRATION DURING HEMODIALYSIS (HD) THERAPY. THE PATIENT WEIGHED 700 GRAMS LESS THAN EXPECTED. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.