FDA.reportPublic FDA data

MAUDE MDR 722581

MDR report key
722581
Report number
1225520-2006-00002
Event key
0
Event type
3
Date of event
2006-04-28
Date received
2006-06-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JOHN BONASERA
Address
40 GRISSOM RD. PLYMOUTH MA 02360 US
Phone
508-508-5087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SMARTPREP PLATELET CONCENTRATE SYSTEMCENTRIFUGE, BLOOD PROCESSINGHARVEST TECHNOLOGIES, CORP.JQCSMP 1000SMP 1000NANYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-06-0201. O

Event Narratives#

D

Patient 1

BLOOD WAS SPILLED FROM THE PROCESSING DISPOSABLE (PD) INTO THE CENTRIFUGE BOWL. THERE WAS NO INJURY. THE PD WAS DISCARDED BY THE USER AND NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. THE CENTRIFUGE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND BLOOD STAINS ON THE REAR OF THE CENTRIFUGE AND IN THE BOWL. THE GASKET WAS NOT TACKY AND NOT SEATED. THE HALL EFFECT SENSOR WAS DAMAGED WHICH WOULD RESULT IN THE MOTOR EXCEEDING THE NORMAL RPM. A PROCESSING CYCLE WAS PERFORMED WITH TWO PRP-20 PROCESSING DISPOSABLE TAKEN FROM INVENTORY AND FILLED WITH WATER. THE REPORTED EVENT WAS REPRODUCED. THE HIGH RPM CAUSED A CRACK TO DEVELOP IN THE BOTTOM OF THE WHOLE BLOOD TUBE IN EACH PROCESSING DISPOSABLE FROM WHICH FLUID LEAKED INTO THE BOWL AND PAST THE GASKET ONTO THE REAR COVER AND PANEL. THE CENTRIFUGE WAS SCRAPPED DUE TO THE STAINS. A REPLACEMENT MACHINE WAS SENT TO THE CUSTOMER.