FDA.reportPublic FDA data

MAUDE MDR 463278

MDR report key
463278
Report number
1225520-2003-00003
Event key
0
Event type
3
Date of event
2003-05-02
Date received
2003-05-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JOHN BONASERA DIRECTOR
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
1SMP-2 CENTRIFUGE & APC-60ML PROCESS PACKCENTRIFUGE BLOOD PROCESSING & ACCESSORYHARVEST TECHNOLOGIES, CORP.JQCAPC-60 SMP2-115APC-60 SMP2-115*NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-05-270

Event Narratives#

D

Patient 1

IN 2003, A APC-60 PROCESSING DISPOSABLE ACCESSORY WHOLE BLOOD CHAMBER CRACKED AND SEPARATED FROM THE PD BODY DURING CENTRIFUGATION. A SMALL AMOUNT OF BLOOD SPILLED INTO THE ENCLOSED CENTRIFUGE CHAMBER. THE SPILLED BLOOD WAS CONTAINED WITHIN THE SEALED CENTRIFUGE CHAMBER. NO INJURY RESULTED FROM THIS INCIDENT THIS INCIDENT DID NOT RESULT IN AN EXPOSURE AS DEFINED BY OSHA. THE CENTRIFUGE WAS RETURNED TO HARVEST. THE ACTUAL PROCESS DISPOSABLE WAS DISCARDED AND THE LOT NUMBER IS UNK. AN INVESTIGATION FOUND THAT BLOOD WAS IN THE CENTRIFUGE CHAMBER. THERE WAS AN INDICATION THAT A PROCESS DISPOSABLE HAD AT ONE TIME NOT BEEN FULLY SEATED INTO THE CENTRIFUGE AND SCRAPED THE TOP WINDOW AS IT ROTATED. HOWEVER, THAT EVENT APPEARS NOT RELATED TO THIS REPORTED INCIDENT. THE CENTRIFUGE OTHERWISE APPEARED AND FUNCTIONED NORMALLY.