inforMED
KRL

SORIN S5 BUBBLE DETECTOR

Received Oct 7, 2016 · Event occurred Sep 7, 2016

Report 9611109-2016-00665 · MDR key 6012750

Device

Generic name

Detector, Bubble, Cardiopulmonary Bypass

Model number

23-07-50

Product problems

  • Material Integrity Problem
  • Material Integrity Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP SYSTEM. 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 CUSHIONS WERE FOUND TO BE DEFLATED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS UNABLE TO IDENTIFY THE ISSUE ON SITE. THE BUBBLE SENSOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. 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 CUSHIONS WERE FOUND TO BE DEFLATED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

Remedial action

  • Other