inforMED
MalfunctionKRL

TERUMO PERFUSION SYSTEM

Received Aug 24, 2007 · Event occurred Jul 25, 2007

Report 1828100-2007-00276 · MDR key 903246

Device

Generic name

Air Sensor

Model number

5773

Catalog number

5773

Product problems

  • Sensor problems

Patient

YR

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE FAILURE WAS REPRODUCED BY MOVING/AGITATING ONE END OF THE AIR SENSOR CABLE. THE CABLE WAS FOUND TO HAVE AN INTERMITTENT CONNECTION ON ONE OF THE WIRES. DISASSEMBLY OF THE CABLE FOUND THE WIRE WAS LOOSE WITHIN THE SOLDER CUP AND AN INSUFFICIENT AMOUNT OF SOLDER WITHIN THE CUP. SOLDERING THE WIRE PROPERLY TO THE CUP RESULTED IN AN ELIMINATION OF THE PROBLEM.

Description of Event or Problem

DURING CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR ISSUED FALSE AIR BUBBLE ALARMS. THE SENSOR CABLE WAS REPLACED. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.