MAUDE MDR 9908370

MDR report key
9908370
Report number
3012307300-2020-02560
Event key
0
Event type
3
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
1CADD LEGACY 1 PUMPPUMP, INFUSIONSMITHS MEDICAL ASD, INC.FRN640021-6400-51N R

Patients#

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

Event Narratives#

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD LEGACY 1 PUMP HAD AN ERROR CODE 1720 DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.