MalfunctionKRL
TERUMO PERFUSION SYSTEM 8000
Received Jul 7, 2010 · Event occurred Jun 17, 2010
Report 1828100-2010-00772 · MDR key 1750363
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Product problems
- Device Alarm System
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PRIME IN PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE AIR BUBBLE DETECTOR ALARM OCCURRED CONTINUOUSLY. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. NO OTHER DETAILS REGARDING THE EVENT WERE PROVIDED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.