FDA.reportPublic FDA data

MAUDE MDR 9908384

MDR report key
9908384
Report number
3012307300-2020-02622
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
Phone
383-383-3833
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDFUSION PUMPPUMP, INFUSIONSMITHS MEDICAL ASD, INC.FRN35003500Y R

Patients#

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

Event Narratives#

N

Patient 1

ONE MEDFUSION PUMP WAS RECEIVED WITH THE TOP AND BOTTOM CASES IN EXCELLENT CONDITION AND NO VISIBLE CONTAMINATION. THE EVENT HISTORY LOG WAS REVIEWED AND A MOTOR RATE ERROR WAS FOUND IN THE HISTORY. AN OCCLUSION TEST WAS PERFORMED AND A MOTOR RATE ERROR WAS DUPLICATED WHEN USING THE SAME INFUSION RATE AS THE USER. THE MAIN PRINTED CIRCUIT BOARD (PCB) NO LONGER OPERATED AS A RESULT OF NORMAL WEAR; THE PUMP WAS OVER 13 YEARS OLD. THE PCB WAS REPLACED TO RESOLVE THE ISSUE.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL HAD A MOTOR ERROR AND IT WAS INTERMITTENT/ THERE WAS NO PATIENT INVOLVEMENT.