SORIN S5 BUBBLE DETECTOR
Received Oct 13, 2016 · Event occurred Sep 16, 2016
Report 9611109-2016-00660 · MDR key 6029007
Device
Generic name
Bubble Sensor Tubing 3/8 Sorin S5 System
Manufacturer
Sorin Group DeutschlandModel number
23-07-50Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DURING THE COMPLAINT INVESTIGATION, IT WAS DETERMINED THAT THIS IS NOT A REPORTABLE MALFUNCTION, AS THE FUNCTIONALITY OF THE DEVICE IS NOT AFFECTED. THE INITIAL REPORT, SUBMITTED ON (B)(6) 2016 CAN BE VOIDED. NO FURTHER FOLLOW-UPS WILL BE FILED FOR THIS EVENT.
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 GAVE AN INCORRECT READING DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A REPLACEMENT BUBBLE SENSOR WAS PROVIDED TO THE CUSTOMER FOR INSTALLATION. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER CONFIRMED THAT THE REPLACEMENT RESOLVED THE REPORTED ISSUE AND THE UNIT IS NOW FUNCTIONING AS EXPECTED. THE REPLACED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR 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 GAVE AN INCORRECT READING DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.
Remedial action
- Other