FDA.reportPublic FDA data

MAUDE MDR 6732163

MDR report key
6732163
Report number
1722028-2017-00298
Event key
0
Event type
3
Date of event
2017-06-28
Date received
2017-07-21
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 SMP2, 115V, 20/60 BWTERUMO BCTJQCSMP211500R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-2101. O

Event Narratives#

N

Patient 1

ADDITIONAL PRODUCT CODE: FMF. INVESTIGATION: THE MACHINE WAS RETURNED TO TERUMO BCT FOR REPAIR AND INVESTIGATION. A SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND CONFIRMED THAT THE LID LATCH WAS OUT OF ADJUSTMENT. A NEW LATCH AND MAGNET PLATE WAS INSTALLED AND THE LID LATCH WAS REALIGNED. A SIMULATED USE TEST WAS PERFORMED AND CONFIRMED THAT THE LID STAYED CLOSED THROUGH THREE FULL CYCLES. THE MACHINE IS FUNCTIONING WITHIN SPECIFICATION. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE LID OF A SMART PREP 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.