FDA.reportPublic FDA data

MAUDE MDR 9908441

MDR report key
9908441
Report number
3012307300-2020-02611
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 SYRINGE PUMPPUMP, INFUSIONSMITHS MEDICAL ASD, INC.FRN35003500Y R

Patients#

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

Event Narratives#

N

Patient 1

RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION BUT WITH A CRACK RIGHT PLUNGER CASE. NO EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE, THE CLICKING SOUND WAS HEARD AND THE PUMP WAS RUNNING LOUD DURING TESTING. A LACK OF SILICON GREASE IN THE WORM COUPLING CAVITY AND PLUNGER TUBE WERE FOUND TO BE THE CAUSE OF THE COMPLAINT. THIS WAS DUE TO NORMAL WEAR. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION SYRINGE PUMP HAD A CLICKING SOUND IN THE PLUNGER AND IT APPEARED TO CAUSE OCCLUSIONS. NO ADVERSE EVENTS WERE REPORTED.