MalfunctionKRL
TERUMO ADVANCED PERFUSION SYSTEM 1
Received Jul 14, 2009 · Event occurred Jun 16, 2009
Report 1828100-2009-00305 · MDR key 1480749
Device
Generic name
Air Bubble Detector
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5773Catalog number
5773
Product problems
- Sensor problems
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE AIR BUBBLE DETECTOR CAUSED THE ROLLER PUMP TO STOP. THE USER WAS APPARENTLY ABLE TO RECOVER, AND THE DEVICE WAS USED TO CONCLUDE THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION ANTICIPATED, BUT NOT YET BEGUN.