AXP PROCESSING SET
Received Apr 22, 2009 · Event occurred Mar 30, 2009
Report 2950374-2009-00001 · MDR key 1369388
Device
Product problems
- Hole In Material
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE INITIAL REPORT RECEIVED (B)(6) 2009 INDICATED THAT A HOLE WAS OBSERVED IN THE PLASMA BAG CLOSE TO THE VALVE AFTER CENTRIFUGATION. THIS COULD POSSIBLY RESULT IN A SAMPLE LOSS.
Additional Manufacturer Narrative
THE AXP PROCESSING BAG IS THE COMPONENT OF THE AXP PLATFORM UNIT AND ARE SINGLE USE. THE INFO RECEIVED FROM THE USER INDICATED THERE WAS A HOLE IN THE PLASMA BAG CLOSE TO THE VALVE AFTER CENTRIFUGATION. PRODUCT HAS BEEN RECEIVED AND IS UNDER INVESTIGATION. THIS TYPE OF OCCURRENCE POSES NO RISK TO PT OR CAREGIVER. NO ADVERSE EVENT HAS BEEN REPORTED FOR THIS OCCURRENCE. TO ENSURE COMPLIANCE TO THE FDA REPORTING REQUIREMENTS UNDER SECTION 21CF803. THERMOGENESIS HAS TAKEN A CONSERVATIVE APPROACH AND MADE THE DECISION TO SUBMIT THESE TYPES OF OCCURRENCES..