FDA.reportPublic FDA data

MAUDE MDR 9908352

MDR report key
9908352
Report number
3012307300-2020-02623
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 CRACKED RIGHT PLUNGER CASE. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A "CHECK PLUNGER LEVER" ALARM IN THE HISTORY. THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED AFTER MULTIPLE FLOW AND OCCLUSION TESTS FOR THE CHECK CLUTCH ERROR. THE CLUTCH HALF'S LEFT AND RIGHT WITH LEADSCREW AND SPRING WERE REPLACED AS A PREVENTATIVE MEASURE BECAUSE THE PARTS WERE OVER 5 YEARS OLD.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION PUMP FAILED OCCLUSION TEST AND HAD A "CHECK PLUNGER CLUTCH" MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.