FDA.reportPublic FDA data

MAUDE MDR 9907631

MDR report key
9907631
Report number
3012307300-2020-02253
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 N MINNEAPOLIS, MN US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SMITHS MEDICAL CADD SOLIS VIP PUMPPUMP, INFUSIONSMITHS MEDICAL ASD, INC.FRN212021-2120-0102-51Y R

Patients#

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

Event Narratives#

N

Patient 1

ONE INFUSION PUMP WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND IT TO BE IN GOOD PHYSICAL CONDITION. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. DEVICE UNDERWENT DELIVERY ACCURACY TESTING; THE CUSTOMER'S REPORTED PROBLEM REGARDING DELIVERY ACCURACY WAS UNABLE TO BE DUPLICATED. THREE SEPARATE DELIVERY ACCURACY TESTS WERE PER FORMED. ALL WERE WITHIN THE PUMP'S DELIVERY ACCURACY MANUFACTURING SPECIFICATIONS OF +/-6 PERCENT. NO PROBLEMS WERE FOUND WITH THE DELIVERY ACCURACY OF THE PUMP.

D

Patient 1

INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL AMBULATORY INFUSION CADD SOLIS VIP PUMP IS NOT DELIVERING ANYTHING. NO ADVERSE EFFECTS REPORTED.