LS HEMA Y-TP BLD CLV

Description of Event or Problem

THE CUSTOMER CONTACT REPORTED THAT ONE OF THE TUBES THAT LEAD FROM THE SPIKE TO THE DRIP CHAMBER WAS LOOSE, SUBSEQUENTLY A LEAK WAS NOTED. IT WAS REPORTED THAT DURING PRIMING, PRIOR TO PT USE, FLUID WAS FOUND AROUND THE OUTSIDE OF THE DRIP CHAMBER, THE BUBBLES OCCURRING AT THE CONNECTION WHEN DRIP CHAMBER WAS SQUEEZED. IT WAS FURTHER REPORTED, THAT WHEN THE TUBING SET WAS PLACED BACK IN THE PACKAGING, ONE OF THE TUBES THAT LEADS FROM THE SPIKE TO THE BLOOD FILTER HOUSING ASSEMBLY CAME APART WHERE IT ENTERED THE BLOOD FILTER HOUSING ASSEMBLY. THERE WERE NO REPORTED ADVERSE PT EVENTS AND NO REPORTED DELAY OF THERAPY CRITICAL FOR THE PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADD'L INFO WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.