MalfunctionKRL
TERUMO PERFUSION SYSTEM
Received Apr 12, 2006 · Event occurred Mar 14, 2006
Report 1828100-2006-00148 · MDR key 700139
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems CorpModel number
5773Catalog number
5773
Lot number
NA
Product problems
- False Alarm
- Bubble(s)
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING PREVENTIVE MAINTENANCE OF THE HEART LUNG SYSTEM, THE DEVICE UNEXPECTEDLY DISPLAYED A FALSE AIR BUBBLE ALARM. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.