MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM ONE
Received Aug 15, 2006 · Event occurred Jul 19, 2006
Report 1828100-2006-00302 · MDR key 762840
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
802110Catalog number
802110
Lot number
NA
Product problems
- Alarm, audible
- Sensor problems
Patient
*
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION BEGUN, BUT NO CONCLUSIONS DRAWN.
Description of Event or Problem
DURING CARDIOPULMONARY BYPASS, THE DEVICE UNEXPECTEDLY AND CONTINUOUSLY DISPLAYED AN AIR BUBBLE ALARM. THE DEVICE WAS REMOVED FROM SERVICE. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.