FDA.reportPublic FDA data

MAUDE MDR 9908360

MDR report key
9908360
Report number
3012307300-2020-02554
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.FRN640021-6400-51Y R

Patients#

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

Event Narratives#

N

Patient 1

ONE CADD LEGACY 1 PUMP WAS RETURNED FOR ANALYSIS. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS NO EVIDENCE OF THE REPORTED ISSUE. THREE SEPARATE DELIVERY ACCURACY TESTS WERE PERFORMED. THE REPORTED "FAILED ACCURACY" ISSUE WAS UNABLE TO BE CONFIRMED. DELIVERY ACCURACY TESTING FOUND THE PUMPS AVERAGE DELIVERY ERROR TO BE WITHIN THE PUBLISHED SPECIFICATION OF +/-6%. THERE WAS NO FAULT FOUND WITH THE RETURNED PUMP. THE EXPULSOR ASSEMBLY WAS REPLACED AS A PREVENTATIVE ACTION.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD LEGACY 1 PUMP FAILED ACCURACY BY +6.95% DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.