MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Apr 21, 2008 · Event occurred Mar 24, 2008
Report 1828100-2008-00219 · MDR key 1032188
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems CorpModel number
802110Catalog number
802110
Product problems
- Sensor problems
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVAL IN PROGRESS BUT NOT CONCLUDED.
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.