FDA.reportPublic FDA data

MAUDE MDR 3234931

MDR report key
3234931
Report number
1416980-2013-18894
Event key
0
Event type
3
Date of event
2013-06-24
Date received
2013-07-18
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
CHRISTINA ARNT
Address
25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
Phone
224-224-2242
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSTEM 1000SYSTEM, HEMODIALYSIS, ACCESS RECIRCULATION MONITORINGBAXTER HEALTHCARE - LARGOMQSS1000L3PR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-180

Event Narratives#

D

Patient 1

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.

N

Patient 1

(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.

N

Patient 1

(B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED; THE CAUSE WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.