FDA.reportPublic FDA data

MAUDE MDR 1828681

MDR report key
1828681
Report number
1713747-2010-00030
Event key
0
Event type
3
Date of event
2010-07-12
Date received
2010-08-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
MARGARET CHARETTE, RN
Address
920 WINTER ST WALTHAM MA 02451 US
Phone
781-781-7816
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1F6 DIALYZER FINISHED ASSY (CASE)NONEOGDEN MANUFACTURINGMSENAN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-08-230

Event Narratives#

D

Patient 1

A MEDWATCH REPORT HAS BEEN RECEIVED REGARDING AN EVENT WHICH OCCURRED (B)(6) 2010. THIS FACILITY HAS BEEN CONTACTED FOR FURTHER DETAIL REGARDING THIS INCIDENT. REPORTEDLY, THE PT HAD BEEN RECEIVING DIALYSIS WHEN AN INTERNAL BLOOD LEAK WAS DETECTED. THE LEAK WAS REPORTED AS "GROSS" IN THAT VISIBLE BLOOD COULD BE SEEN ENTERING THE DIALYSATE. THE LEAK WAS APPROXIMATELY 157CC'S OF BLOOD LOSS AND NO BLOOD WAS RETURNED TO THE PT. THE PT REQUIRED NO MEDICAL INTERVENTION, HOWEVER, A BLOOD TRANSFUSION HAD BEEN CONSIDERED. THE PT IS REPORTED AS BEING FINE AND A COMPANION SAMPLE IS AVAILABLE FOR AN EVAL. SAMPLES ARE AVAILABLE FOR EVAL.