FDA.reportPublic FDA data

MAUDE MDR 7082776

MDR report key
7082776
Report number
1722028-2017-00462
Event key
0
Event type
3
Date of event
2017-11-10
Date received
2017-12-05
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
STEVE KERN
Address
10810 W. COLLINS AVE LAKEWOOD CO 80215 US
Phone
303-303-3032
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HARVEST TERUMOHARVEST SMARTPREP2, 115VTERUMO BCTJQCSMP211501R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-0501. O

Event Narratives#

N

Patient 1

ADDITIONAL PRODUCT CODE: FMF. INVESTIGATION: THE SMARTPREP DEVICE WAS RETURNED TO TERUMO BCT FOR REPAIR AND EVALUATION. THE SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED CONDITION. THE SERVICE TECHNICIAN NOTED THAT THE LID WAS HARD TO CLOSE COMPLETELY DUE TO THE LATCH BEING OUT OF ADJUSTMENT AND PRESSURE MUST BE APPLIED DOWN SINCE IT WAS VERY HARD TO CLOSE COMPLETELY DUE TO THE LATCH BEING OUT OF ADJUSTMENT. IT WAS ALSO NOTED THAT THE UNIT WILL RUN WITHOUT THE LID BEING COMPLETELY LATCHED BUT AS SOON AS THE LID IS LIFTED SLIGHTLY, THE MAGNET WILL DISENGAGE THE REED SWITCH AND THE UNIT STOPS. NO OTHER FUNCTIONAL ISSUES WERE FOUND. A SIMULATED USE TESTING WERE PERFORMED BY PERFORMING THREE PROCEDURAL CYCLES AND IT WAS OBSERVED THAT THE MOTOR SPUN AT THE CORRECT RPM AND THE DECANTRING ACTIVATED PROPERLY. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

THE CUSTOMER REPORTED THAT THE LID LATCH OF THE SMARTPREP CENTRIFUGE WOULD NOT STAY CLOSED. THERE WAS NOT A DONOR OR PATIENT INVOLVED AT THE TIME OF THE PROCEDURE, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.