MalfunctionKRL
TERUMO PERFUSION SYSTEM 9000
Received Apr 12, 2006 · Event occurred Mar 13, 2006
Report 1828100-2006-00147 · MDR key 700148
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems CorpModel number
164300Catalog number
164300
Lot number
UNK
Product problems
- Alarm, audible
- Defective Alarm
- Bubble(s)
- Failure to Reset
Narrative
Description of Event or Problem
DURING PREPARATION OF THE HEART LUNG SYSTEM FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE AIR SENSOR ALARMED AND COULD NOT BE RESET. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.