FDA.reportPublic FDA data

MAUDE MDR 426339

MDR report key
426339
Report number
2937457-2002-00041
Event key
0
Event type
3
Date of event
2002-10-02
Date received
2002-11-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ELVY DIZON, BSN,RN,CNN
Address
2637 SHADELANDS DRIVE WALNUT CREEK CA 94598 US
Phone
925-925-9252
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FRESENIUS DIALYSIS DELIVERY SYSTEMHEMODIALYSIS MACHINEFRESENIUS MEDICAL CARE-NORTH AMERICAFIL2008KNANAK994267NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-11-010

Event Narratives#

D

Patient 1

A DIALYSIS FACILITY REPORTED THAT THERE WAS EXCESSIVE FLUID REMOVED FROM A PT DURING A HEMODIALYSIS TREATMENT. THE PT C/O CRAMPS 15MIN. BEFORE THE END OF TREATMENT AND WAS GIVEN 300CC OF SALINE. BASED ON THE PRE AND POST WEIGHTS, SALINE GIVEN AND WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS FLUID WEIGHT LOSS VARIANCE OF APPROX 1.9KG. THE PT WAS DISCHARGED IN STABLE CONDITION.