FDA.reportPublic FDA data

MAUDE MDR 9908381

MDR report key
9908381
Report number
3012307300-2020-02626
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 RETURNED WITH A CRACK ON THE TOP CASE BY THE TUBE HOLDERS, A CRACK ON THE RIGHT PLUNGER CASE AND BOTTOM CASE AS WELL AS A MISSING BATTERY AND BATTERY DOOR. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A MOTOR NOT RUNNING ERROR. AN OCCLUSION TEST WAS PERFORMED AND A MOTOR NOT RUNNING ERROR WAS FOUND. THE ISSUE WAS CAUSED BY A COMBINATION OF THE OLD STYLE MOTOR BRACKET, WORM COUPLING, LEADSCREW AND CLUTCH HALVES WHICH WERE FOUND OLD, DIRTY AND WORN OUT. THE ISSUE WAS CAUSED BY NORMAL WEAR SINCE THE PUMP IS OVER 13 YEARS OLD. THE DEFECTIVE COMPONENTS WERE REPLACED TO RESOLVE THE ISSUE.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION PUMP FAILED OCCLUSION TEST. THERE WAS NO PATIENT INVOLVEMENT.