MalfunctionDTZ
INSPIRE
Received May 26, 2026 · Event occurred Mar 25, 2026
Report 25277465 · MDR key 25277465
Device
Generic name
Oxygenator, Cardiopulmonary Bypass
Manufacturer
Sorin Group Italia S.r.lCatalog number
260070042
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE ARTERIAL TEMP PROBE HOUSING ON THE OXYGENATOR DID NOT APPEAR TO BE BONDED TO THE OXYGENATOR AND A SIGNIFICANT LEAK OCCURRED REQUIRING CHANGE OUT OF THE CIRCUIT. NO PATIENT WAS CONNECTED OR SUPPORTED BY THE CIRCUIT AT THE TIME OF THE INCIDENT. THIS OCCURRED DURING SET UP OF THE EQUIPMENT.