BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE

Description of Event or Problem

IT WAS REPORTED THAT DURING USE ON A PT. ACCUMULATION OF AIR WAS OBSERVED ON THE LOWER SIDE OF THE DE-AIRING COCK. AIR ACCUMULATION WAS OBSERVED SOON AFTER MANIPULATING THE DE-AIRING COCK. THE CUSTOMER SUSPECTS THE FAILURE IS DUE TO THE BACK-FLOW VALVE AND/ OR THE PRODUCT HOUSING. DEVICE USE WAS CONTINUED WITH NO REPORTED PT EFFECT. BLOOD FLOW RATE: 3.6L/MIN. ASPIRATION PRESSURE: -56MMHG".(B)(4).

Additional Manufacturer Narrative

(B)(4). A HEALTH HAZARD EVAL WAS INITIATED AND THE HAZARD HAS BEEN DEFINED. BASED ON NEW INFO AVAILABLE (B)(4) 2014, A RE-ASSESSMENT OF THE REPORTING OBLIGATION WAS PERFORMED AND THIS EVENT WAS DETERMINED TO BE REPORTABLE. MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS AND AN INTERNAL PROCESS (B)(4) WAS INITIATED TO DETERMINE THE ROOT- CAUSE AND IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADD'L INFO BECOMES AVAILABLE.