FDA.reportPublic FDA data

MAUDE MDR 9906432

MDR report key
9906432
Report number
3012307300-2020-02491
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
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CADD MS3 PUMPPUMP, INFUSIONSMITHS MEDICAL ASD, INC.FRN740021-7411-51Y R

Patients#

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

Event Narratives#

N

Patient 1

ONE SMITHS MEDICAL CADD MS3 PUMP WAS RETURNED FOR ANALYSIS. DURING INVESTIGATION, THE REPORTED ISSUE WAS NOT ABLE TO BE VERIFIED. SERVICE REPAIRED THE PUMP FOR OTHER ISSUES FOUND DURING INVESTIGATION. BASED ON THE EVIDENCE, THE REPORTED COMPLAINT WAS NOT CONFIRMED, AND THE PROBLEM SOURCE OF THE REPORTED EVENT IS UNKNOWN.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD MS3 PUMP POWERED OFF RANDOMLY. IT WAS NOT SPECIFIED WHETHER THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. NO ADVERSE EFFECTS WERE REPORTED.