inforMED
MalfunctionKRL

SORIN S5 BUBBLE DETECTOR FOR 3/8 TUBING

Received Sep 27, 2016 · Event occurred Oct 15, 2015

Report 9611109-2016-00678 · MDR key 5982188

Device

Generic name

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

Model number

23-07-50

Product problems

  • Physical Property Issue
  • Physical Property Issue

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

SORIN GROUP (B)(4) MANUFACTURES THE SORIN S5 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S5 BUBBLE DETECTOR WAS FOUND TO HAVE DEFLATED CUSHIONS. THIS ISSUE WAS DISCOVERED BY A SORIN GROUP FIELD SERVICE REPRESENTATIVE DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE REPRESENTATIVE REPLACED THE BUBBLE SENSOR AND PERFORMED A FUNCTIONAL CHECK AND TRIAL RUN. NO FURTHER ISSUES WERE DISCOVERED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S5 BUBBLE DETECTOR WAS FOUND TO HAVE DEFLATED CUSHIONS. THIS ISSUE WAS DISCOVERED BY A SORIN GROUP FIELD SERVICE REPRESENTATIVE DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

Remedial action

  • Other