FDA.reportPublic FDA data

MAUDE MDR 709436

MDR report key
709436
Report number
1225520-2006-00001
Event key
0
Event type
3
Date of event
2006-04-14
Date received
2006-05-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BILL MCCALLUM, MANAGER
Address
40 GRISSOM RD., SUITE 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
1SMARTPREP2 PC SYSTEM & ACCESSORYCENTRIFUGE BLOOD PROCESSING & ACCESSORYHARVEST TECHNOLOGIESJQCNA2761-02-120HTI-120-0031NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-05-0401. O

Event Narratives#

D

Patient 1

THE PROCESS DISPOSABLE CRACKED DURING CENTRIFUGATION ALLOWING BLOOD TO LEAK. IMPROPER ORIENTATION OF PROCESS DISPOSABLE (BY THE USER) PUT PRESSURE ON CENTRIFUGE LID COMPROMISING LID SEAL ALLOWING BLOOD TO ESCAPE THE CENTRIFUGE CHAMBER. NO INJURY TO OPERATOR OR PATIENT.