OtherOAO
AXP AUTOXPRESS PLATFORM
Received Dec 8, 2008 · Event occurred Nov 11, 2008
Report 2950374-2008-00003 · MDR key 1258146
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
A CUSTOMER CALL CAME IN ON (B)(6)2008, TO REPORT THAT WHITE DEBRIS WAS FOUND IN THE DISPOSABLE FREEZING BAG.
Additional Manufacturer Narrative
WE HAVE COMPLETED OUR EVAL OF THE RETURNED DISPOSABLE BAGSET. THE WHITE DEBRIS WAS SENT OUT FOR FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY FOR IDENTIFICATION. THE PARTICLE WAS IDENTIFIED AS BAGSET STOPCOCK MATERIAL. THIS IS AN ISOLATED EVENT FOR THIS LOT OF DISPOSABLE BAGSETS FROM THIS MFR. WE WILL CONTINUE TO MONITOR AND TREND. NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS OCCURRENCE.