Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W

Additional Manufacturer Narrative

IN-DEPTH ANALYSIS WILL BE PERFORMED TO UNDERSTAND THE ROOTE CAUSE OF THE PROBLEM ENCOUNTERED. ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER COMPLETION OF INVESTIGATION ACTIVITIES, WHICH WOULD BE ADDRESSED IN A FOLLOW-UP REPORT.

Description of Event or Problem

TH USER REPORTED THAT DURING THE BYPASS CUSTOMER HAVE NOTICED A CONTAMINATION WITH BLOOD. NO ADVERSE CONSEQUENCES OCCURRED FOR THE PATIENT.