FDA.reportPublic FDA data

MAUDE MDR 6978001

MDR report key
6978001
Report number
1722028-2017-00417
Event key
0
Event type
3
Date of event
2017-09-12
Date received
2017-10-25
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 TERUMOSMP2-115V HARVEST 20/60TERUMO BCTJQCSMP2115R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-2501. 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. A SIMULATED USE TEST WAS PERFORMED BY PERFORMING FOUR FULL PROCEDURAL CYCLES WITH NO ISSUES NOTED. AT THE START OF THE FIFTH CYCLE, THE SERVICE TECHNICIAN NOTICED THAT THE DECANT SOLENOIDS ACTIVATED THE LID SOLENOID CAUSING THE LID TO OPEN. HOWEVER, IT DID NOT OPEN ENOUGH TO STOP THE SMARTPREP DEVICE FROM RUNNING. AFTER SLIGHTLY LIFTING THE LID, THE REED SWITCH DETECTED THE OPEN LID AND SHUT DOWN THE UNIT. THE MAIN CONTROL BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE SMARTPREP DISPLAY BOARD, DISPLAY PANEL, RIBBON CABLE, AND MEMBRANE SWITCH WERE REPLACED FOR COMPATIBILITY WITH THE NEW CONTROL BOARD. THE VIBRATION ISOLATION, LATCH PLUNGER SPRINGS, FEET, WINDOW, GASKET AND MAGNET PLATE WERE PROACTIVE REPLACEMENTS. THE LATCH WAS ADJUSTED TO MEET THE 25LBS. LATCHING REQUIREMENT. ALL FUNCTIONAL TESTS WERE SUCCESSFULLY PERFORMED WITH NO ISSUES AFTER THE REPAIR. AN INTERNAL REPORT SHOWS THAT THE MACHINE HAS BEEN IN USE WITH NO FURTHER OCCURRENCES OF THE PROBLEM. ONE YEAR OF SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE WITH NO PROBLEMS IDENTIFIED RELATED TO THE REPORTED CONDITION. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF THE IV POLED ROPPING DOWN SUDDENLY. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

THE CUSTOMER REPORTED THAT AFTER THE FIRST CENTRIFUGE SPIN, THE SMARTPREP DEVICE STOPS THE CENTRIFUGE AND UNLOCKS THE LID LATCH. 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.