MalfunctionKRJ
FILTER, PRE BYPASS
Received Feb 27, 2012 · Event occurred Feb 10, 2012
Report 2494521 · MDR key 2494521
Device
Generic name
Disposable Product (describe Below)
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
PRE-BYPASS PLUS .2 MICRO FILTERCatalog number
72698
Lot number
NP19
Product problems
- Occlusion Within Device
- Manufacturing, Packaging or Shipping Problem
Patient
65 YR
- No Patient Involvement
Narrative
Description of Event or Problem
A PRE-BYPASS FILTER USED WITH THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT OCCLUDED DURING SET UP FOR AN UNKNOWN REASON. THERE WAS NO PT EXPOSURE. THE PRE-BYPASS FILTER FAILED TO OPERATE CORRECTLY. IT APPEARS TO HAVE COME FROM THE FACTORY SEALED ON THE INFLOW SIDE.