FDA.reportPublic FDA data

MAUDE MDR 6689952

MDR report key
6689952
Report number
1722028-2017-00290
Event key
0
Event type
3
Date of event
2017-06-22
Date received
2017-07-06
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 TERUMOSMARTPREP 2-115V 20/60 BWTERUMO BCTJQCSMP211500R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-0601. O

Event Narratives#

N

Patient 1

ADDITIONAL PRODUCT CODE: FMF INVESTIGATION: A MACHINE CHECKOUT WAS PERFORMED BY A TERUMO BCT SEVICE TECHNICIAN AND WAS ABLE TO DUPLICATE THE REPORTED CONDITION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE LID LATCH MAGNET WAS FOUND OUT OF ALIGNMENT AND THE MAGNET WAS UNABLE TO ACTIVATE THE REED SWITCH BEFORE THE LID WAS COMPLETELY LATCHED. THE SERVICE TECHNICIAN REPLACED AND ADJUSTED THE MAGNET PLATE PER MANUFACTURER'S SPECIFICATION. THREE OPERATIONAL RUNS WAS SUCCESFFULLY PERFORMED ON THE DEVICE.INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

THE CUSTOMER REPORTED THAT A SMARTPREP CENTRIFUGE LID LATCH WAS NOT FUNCTIONING PROPERLY AND THE DEVICE WAS RETURNED FOR REPAIR AND EVALUATION. UPON EVALUATION OF THE DEVICE, THE TERUMOBCT SERVICE TECHNICIAN NOTED THAT THE CENTIFUGE LID POPPED OPEN WHILE THE ROTOR WAS STILL SPINNING.THERE WAS NOT A DONOR OR PATIENT INVOLVED AT THE TIME OF THE INCIDENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.