FDA.reportPublic FDA data

MAUDE MDR 9908336

MDR report key
9908336
Report number
3012307300-2020-02436
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 COMPLAINT VERIFIED WHEN TESTED. THE PROBLEM WAS ISOLATED TO DSO (DOWNSTREAM OCCLUSION SENSOR) OTHER ISSUES WERE FOUND AND REPAIRED ON THE DEVICE; S182 C181 R145. NO FURTHER INVESTIGATION INFORMATION OTHER THAN REVEALING THE DHR REVIEW REVEALED NO ISSUE IDENTIFIED PRIOR TO RELEASE OF DEVICE

D

Patient 1

INFORMATION RECEIVED A SMITHS MEDICAL CADD MS3 GRAY SLATE PUMP PER MEDWATCH ALARM BLOCKAGE WHEN LOADING CARTRIDGE. NO PATIENT ADVERSE EVENTS REPORTED.