MalfunctionOET
QUEST
Received Jun 25, 2009 · Event occurred Jun 11, 2009
Report MW5011746 · MDR key 1410840
Device
Product problems
- Fluid/Blood Leak
- Hole In Material
Patient
59 YR
- No Information
Narrative
Description of Event or Problem
THE QUEST DELIVERY SET LEAKED WHILE DELIVERY CARDIOPLEGIA TO A PATIENT. THE SET HAD TO BE CHANGED OUT WHILE ON CARDIOPULMONARY BYPASS. AFTER INSPECTION, THERE WAS A HOLE LOCATED ON THE UPPER SIDE OF THE LEFT BLADDER OF THE DELIVERY SET.