FDA.reportPublic FDA data

MAUDE MDR 6360550

MDR report key
6360550
Report number
6360550
Event key
0
Event type
3
Date of event
2016-12-23
Date received
2017-02-27
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CENTRISOL ACID CONCENTRATESYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENTMEDIVATORS INC.FKQSB-130SB-130820319* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-270

Event Narratives#

N

Patient 1

D

Patient 1

TWO VERY DIFFERENT DIALYSIS SOLUTIONS (BOTH ACIDS) BUT WITH DIFFERENT INGREDIENTS HAVE SUCH SIMILAR LABELS THAT STAFF PULLED THE WRONG ITEM FROM SUPPLY. MISTAKE WAS CAUGHT BEFORE IT WAS USED, HOWEVER CONCERN THAT THE LABELS SHOULD MORE CLEARLY CONVEY THE DIFFERENCE SUCH AS DIFFERENT COLORS.