OtherDTZ
OXYGENATOR
Received Oct 12, 2005 · Event occurred Oct 5, 2005
Report 641169 · MDR key 641169
Device
Product problems
- Malfunction
Patient
60 YR
- Low Oxygen Saturation
Narrative
Description of Event or Problem
DURING OPEN HEART SURGERY (CABG), THE OXYGENATOR FAILED, O2 SATS WERE NOT WELL MAINTAINED. FOAM COMING OUT OF EXHAUST PORTS FROM THE RESERVOIR. NO INJURY TO PT - ALERT, ORIENTED AND RECUPERATING FROM COMPLETED SURGERY.