FDA.reportPublic FDA data

MAUDE MDR 9908383

MDR report key
9908383
Report number
3012307300-2020-02628
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.FRN35003500-500Y R

Patients#

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

Event Narratives#

N

Patient 1

ONE MEDFUSION PUMP WAS RECEIVED IN GOOD PHYSICAL CONDITION WITH NO APPEARANCE OF ANY EXTERNAL DAMAGE. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A FORCE SENSOR BRIDGE TEST ERROR. THE PUMP WAS STARTED UP AND THE REPORTED ISSUE WAS ABLE TO BE REPLICATED. THE PLUNGER CABLE NO LONGER OPERATED AS A RESULT OF NORMAL WEAR; THE PUMP WAS OVER 8 YEARS OLD. THE PLUNGER CABLE WAS REPLACED TO RESOLVE THE ISSUE. THE FORCE SENSOR WAS REPLACED AS A PREVENTATIVE MEASURE. AFTER REPLACING THE FORCE SENSOR, PLUNGER CABLE AND THE PLUNGER BOARD, THE PUMP CONTINUED TO GIVE THE FORCE SENSOR TEST ALARM. THE MAIN BOARD WAS ALSO REPLACED.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION PUMP HAD A FORCE SENSOR TEST ALARM. THERE WAS NO PATIENT INVOLVEMENT.