FDA.reportPublic FDA data

MAUDE MDR 342174

MDR report key
342174
Report number
1225520-2001-00002
Event key
0
Event type
3
Date of event
2001-06-20
Date received
2001-07-12
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
RICHARD LARIVIERE
Address
40 GRISSOM RD STE 100 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 PC SYSTEMCENTRIFUGE (BLOOD PROCESSING)HARVEST TECHNOLOGIES, CORP.JQCSMP1000SMP 1000VP7AH4 (PROCESS DISP)NRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-07-1201. O

Event Narratives#

D

Patient 1

PROCESS DISPOSABLE CRACKED DURING CENTRIFUGATION ALLOWING BLOOD TO LEAK INTO CENTRIFUGE WELL. BLOOD WAS CONTAINED WITHIN CENTRIFUGE CHAMBER. NO INJURY TO OPERATOR OR PATIENT RESULTED. INCIDENT DID NOT RESULT IN EXPOSURE AS DEFINED BY OSHA.