FDA.reportPublic FDA data

MAUDE MDR 9908341

MDR report key
9908341
Report number
3012307300-2020-02440
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 REPORTED PROBLEM OF PUMP POWERING OFF RANDOMLY WAS NOT VERIFIED. THE SOFTWARE WAS REPLACED AS A PREVENTIVE MEASURE. OTHER ISSUES WERE FOUND AND REPAIRED ON DEVICE; S127 C000 R000. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.

D

Patient 1

INFORMATION RECEIVED A SMITHS MEDICAL CADD MS3 GRAY SLATE PUMP POWERS OFF RANDOMLY. NO PATIENT ADVERSE EVENTS REPORTED.