FDA.reportPublic FDA data

MAUDE MDR 456789

MDR report key
456789
Report number
1225520-2003-00002
Event key
0
Event type
3
Date of event
2003-03-28
Date received
2003-04-24
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, DIR
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
1SYMPHONY II PC SYSTEM & FS-60 (ACCESSORY)CENTRIFUGE BLOOD PROCESSING UNIT & ACCESSHARVEST TECHNOLOGIES, CORP.JQCDEPUY-ACROMED2761-02-000SMP2-0505NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-04-2401. O

Event Narratives#

D

Patient 1

A PROCESS DISPOSABLE WAS REPORTED TO HAVE LEAKED BLOOD INTO THE CENTRIFUGE WELL. SUBSEQUENT CONVERSATION WITH THE OPERATORS OF THE MACHINE, REVEALED THAT THE PROCESS DISPOSABLE WAS NOT INSERTED PROPERLY (I.E. AS DESCRIBED IN THE OPERATOR "INSTRUCTIONS FOR USE.") THIS FACT WAS LATER CONFIRMED BY EXAMINATION OF THE CENTRIFUGE INVOLVED IN THE EVENT. THERE WAS NO INJURY TO THE OPERATOR OR PATIENT. THIS INCIDENT DID NOT RESULT IN AN EXPOSURE AS DEFINED BY OSHA.