MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received May 14, 2008 · Event occurred Apr 23, 2008
Report 1828100-2008-00269 · MDR key 1046335
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
802110Catalog number
802110
Product problems
- Sensor problems
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING INSTALLATION OF THE DEVICE, THE AIR BUBBLE DETECTION SYSTEM DID NOT FUNCTION. A REPLACEMENT DETECTOR WAS PROVIDED. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS BUT NOT CONCLUDED.