MalfunctionMNJ
VACUUM RELIEF VALVE IIC-CLEAR
Received May 16, 2006 · Event occurred Apr 28, 2006
Report 1649914-2006-00047 · MDR key 717926
Device
Generic name
Vacuum Relief Valve
Manufacturer
Quest Medical, Inc.Model number
4004103Catalog number
*
Lot number
25259.C11
Product problems
- Fluid/Blood Leak
- Replace
- Valve(s), defective
Patient
UNKNOWN
- Blood Loss
Narrative
Description of Event or Problem
WHILE GIVING CARDIOPLEGIA, THE SURGEON NOTICED THAT THE HEART WAS NOT STOPPING. THE SURGEON REQUESTED INCREASED CARDIOPLEGIA AND THEN NOTICED BLOOD ON FLOOR. THE PERFUSIONIST CHECKED THE CIRCUIT AND NOTED BLOOD AROUND VALVE. THE VALVE WAS REPLACED AND NO FURTHER INCIDENTS WERE REPOATED. THE PRODUCT WAS SAVED AND WILL BE RETURNED. PRODUCT CODE 400103, LOT NUMBER IS EITHER 25259.C11 OR 25775.E09
Additional Manufacturer Narrative
ADDITIONAL LOT# 25775.E09, ADDITIONAL EXP DATE: 01/30/2009.