FDA.reportPublic FDA data

MAUDE MDR 9908334

MDR report key
9908334
Report number
3012307300-2020-02438
Event key
0
Event type
3
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DAVE HALVERSON
Address
6000 LANE N 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 GRAY SLATEPUMP, INFUSIONSMITHS MEDICAL ASD,INCFRN740021-7411-51Y R

Patients#

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

Event Narratives#

N

Patient 1

INVESTIGATION COMPLETED ON A SMITH MEDICAL CADD MS3 PUMP. THE EVALUATIONS AND TESTING WAS DONE AND VERIFIED THE PROBLEM OF NOT SHOWING START INFUSION MENU. THIS WAS ISOLATED TO FAILED PRESSURE SENSOR TEST. THE DSO ( DOWNSTREAM OCCLUSION SENSOR) WAS DEFECTIVE DUE TO IT BE SHATTERED. DEVICE OVERALL CONDITION WAS GOOD. DEVICE WENT ON AND PASSED ALL TESTING.

D

Patient 1

INFORMATION RECEIVED A SMITHS MEDICAL CADD MS3 GRAY SLATE PUMP PER MEDWATCH FORM PUMP NOT SHOWING THE START INFUSION MENU. NO PATIENT ADVERSE EVENTS REPORTED.