FDA.reportPublic FDA data

MAUDE MDR 667364

MDR report key
667364
Report number
1423500-2006-00092
Event key
0
Event type
3
Date of event
2005-12-01
Date received
2006-01-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHRISTIANA BIELINSKI, MANAGER
Address
ROUTE 120 & WILSON ROAD ROUND LAKE IL 60073 US
Phone
847-847-8472
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSTEM 1000 SPDSSYSTEM 1000BAXTER HEALTHCARE CORPORATIONKPFNANANANYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-01-160

Event Narratives#

D

Patient 1

IN 2005, THE FACILITY REPORTED TO BAXTER CUSTOMER SERVICES THAT A SYSTEM 1000 HEMODIALYSIS INSTRUMENT HAD HIGH BACTERIA COUNTS. THIS WAS DISCOVERED DURING BIO-MED TESTING, BEFORE A PT WAS CONNECTED TO THE DEVICE. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED IN ASSOCIATION TO THIS INCIDENT. A BAXTER FIELD SVC ENGINEER WENT TO THE FACILITY TO EVALUATE THE INSTRUMENT IN 2005. THE BAXTER REP FOUND A LEAK AT THE FEMALE BLEACH FITTING. REPLACED THE FEMALE BLEACH FITTING AND THE BLUE DIALYZER CONNECTOR. A SVC CALL REPORT WAS COMPLETED AND ALL SYSTEMS FUNCTIONED PER MANUFACTURER'S SPECIFICATIONS.