inforMED
MalfunctionKRL

SORIN S3 BUBBLE DETECTOR

Received Feb 13, 2017 · Event occurred Jan 19, 2017

Report 9611109-2017-00069 · MDR key 6326117

Device

Generic name

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

Model number

23-07-50

Product problems

  • False Alarm
  • Pumping Stopped
  • False Alarm
  • Pumping Stopped

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS INFORMED BY THE USER WAS NOT ABLE TO CLEAR THE ALARM VIA CONTROL PANEL SO HE DECIDED TO SWITCH-OFF THE BUBBLE MODULE TO RESOLVE THE REPORTED MALFUNCTION. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE USER INFORMED THE SERVICE REPRESENTATIVE THAT THE ALARM COULD NOT BE CLEARED VIA THE CONTROL PANEL. THE BUBBLE MODULE WAS SWITCHED OFF TO CORRECT THE ISSUE. THE SERVICE REPRESENTATIVE CONFIRMED THE ISSUE AND REPLACED THE DEFECTIVE BUBBLE SENSOR. FUNCTIONAL CONTROL AND A TEST RUN DID NOT IDENTIFY ANY FURTHER ISSUES. A LOAN BUBBLE MODULE HAS BEEN PROVIDED TO THE CUSTOMER WHILE AN INVESTIGATION IS PERFORMED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. 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 S3 BUBBLE DETECTOR CAUSED A FALSE ALARM AND IT TRIGGERED A PUMP STOP DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

Remedial action

  • Other