FDA.reportPublic FDA data

MAUDE MDR 9908376

MDR report key
9908376
Report number
3012307300-2020-02625
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 A CRACK ON THE BATTERY DOOR AS WELL AS THE LEFT AND RIGHT PLUNGER CASES. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS NO ERROR WHICH RELATE TO THE FORCE SENSOR PROBLEM. THE POWER UP PROCESS, CHECK AND FORCE SENSOR TESTS WERE PERFORMED. NO FORCE SENSOR ERROR WAS FOUND AT POWER UP, BUT THE FORCE SENSOR WAS UNABLE TO BE CALIBRATED AND THERE WAS NO FORCE READING. THE FORCE SENSOR CABLE WAS DAMAGED AND PINCHED BY THE LEFT PLUNGER CASE. THIS ISSUE WAS CAUSED BY THE CUSTOMER'S INCORRECT ASSEMBLY OF THE DEVICE WHICH CAUSED DAMAGE TO THE FORCE SENSOR CABLE. THE FORCE SENSOR REPLACED TO RESOLVE THE ISSUE.

D

Patient 1

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