FDA.reportPublic FDA data

MAUDE MDR 9908429

MDR report key
9908429
Report number
3012307300-2020-02430
Event key
0
Event type
3
Date of event
2020-01-31
Date received
2020-03-31
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
DAVE HALVERSON
Address
6000 NATHAN LANE NORTH MINNEAPOLIS, MN US
Phone
383-383-3833
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPESET, ADMINISTRATION, INTRAVASCULARSMITHS MEDICAL ASD, INC.FPA21-7339-243882432N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL ADMINISTRATION SET WAS IMPLICATED IN A MEDICATION NOT BEING DELIVERED TO THE PATIENT. THE PATIENT WAS NOT GETTING COMFORTABLE. IT WAS DISCOVERED THAT NO MEDICATION WAS BEING DELIVERED BY VIEWING THE MEDICATION CONTAINED DESPITE THE PUMP INDICATING MEDICATION WAS BEING DELIVERED. THERE WERE NO ADVERSE EVENTS REPORTED DUE TO THIS EVENT.