FDA.reportPublic FDA data

MAUDE MDR 9908434

MDR report key
9908434
Report number
3012307300-2020-02478
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-MS3 AMBULATORY INFUSION PUMPPUMP, INFUSIONSMITHS MEDICAL ASD, INC.FRN21-7411-517400Y R

Patients#

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

Event Narratives#

N

Patient 1

RETURNED DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS UNABLE TO BE VERIFIED. THE SOFTWARE WAS REPLACED AS A PREVENTATIVE MEASURE. 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-MS3 AMBULATORY INFUSION PUMP LOST ITS PROGRAMMING. THERE WERE NO REPORTED ADVERSE EVENTS.