inforMED
KRL

SORIN S3 BUBB DET

Received Nov 4, 2016 · Event occurred Oct 17, 2016

Report 9611109-2016-00736 · MDR key 6078809

Device

Generic name

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

Model number

23-07-50

Product problems

  • Device Issue
  • Device Issue

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

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). REPLACEMENT PARTS HAVE BEEN PROVIDED TO THE CUSTOMER. THE DEFECTIVE UNIT HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4). 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 S3 BUBBLE DETECTOR WAS FOUND TO BE DEFECTIVE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

Remedial action

  • Other