FDA.reportPublic FDA data

MAUDE MDR 9906427

MDR report key
9906427
Report number
3012307300-2020-02484
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 IN A GOOD CONDITION. DURING ANALYSIS, THE CUSTOMER'S REPORTED PROBLEM WAS UNABLE TO BE DUPLICATED. INSPECTED THE PUMP AND PERFORMED FUNCTIONAL TESTS, IT PASSED ALL TESTS. FURTHER INVESTIGATION OF THE PUMP FOUND NO ISSUE WITH PUMP REGARDING LOST PROGRAMMING. THEREFORE, NO PROBLEM WAS FOUND WITH THE ISSUE. SERVICE RECOMMENDED CUSTOMER TO KEEP IN MIND THAT PROGRAMMING WILL BE LOST AFTER 2 DAYS WITHOUT POWER FROM THE AAA BATTERY AND PAY CLOSE ATTENTION TO THE LOW BATTERY NOTIFICATION. BASED ON THE EVIDENCE, THE COMPLAINT WAS NOT CONFIRMED, AND NO FAULT WAS FOUND.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD MS3 PUMP LOST ITS PROGRAMMING. NO PATIENT WAS INVOLVED IN THIS EVENT. NO ADVERSE EFFECTS WERE REPORTED.