FDA.reportPublic FDA data

MAUDE MDR 9908440

MDR report key
9908440
Report number
3012307300-2020-02512
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 INFUSION SYSTEMPUMP, INFUSIONSMITHS MEDICAL ASD, INC.FRN640021-6400-51Y R

Patients#

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

Event Narratives#

N

Patient 1

RETURNED DEVICE WAS RECEIVED IN FAIR PHYSICAL CONDITION AND THERE WAS A CRACKED HOUSING. EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE, THE ISSUE WAS ABLE TO BE REPLICATED. ANALYSTS WERE ABLE TO CLEAR THE CODE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD LEGACY PUMP WAS PRESENTING WITH ERROR 1310. THERE WERE NO ADVERSE EVENTS REPORTED.