inforMED
MalfunctionKRL

BUBBLE DETECTOR SENSOR

Received Nov 25, 2022 · Event occurred Oct 24, 2022

Report 9611109-2022-00613 · MDR key 15865014

Device

Generic name

Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

Model number

23-07-40

Product problems

  • Low Readings
  • Low Readings

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. LIVANOVA DEUTSCHLAND MANUFACTURES THE BUBBLE DETECTOR SENSOR 1/4". THE INCIDENT OCCURRED IN (B)(6). CARDIOPLEGIA MODULE ERROR OCCURRED. THE CUSTOMER CLEARED THE MESSAGE AND THEN THE S5 SYSTEM COULD BE USED NORMALLY. REPORTEDLY, THE BUBBLE SENSOR USED ON CARDIOPLEGIA LINE DID NOT ALARM AT AIR PRESENCE AND THE PUMP COULD NOT BE STOPPED. IN ADDITION, IT WAS REPORTED THAT WHEN REMOVING THE SENSOR, AN ALARM OCCURRED AND THE PUMP STOPPED. WHEN THE SENSOR WAS RECONNECTED NO ALARM OCCURRED AND THE PUMP CONTINUED TO ROTATE. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY. THE CARDIOPLEGIA MODULE AND THE BUBBLE SENSOR WILL BE REPLACED WITH NEW ONES. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, POST PROCEDURE, S5 SYSTEM GAVE A CARDIOPLEGIA MODULE ERROR MESSAGE AND BUBBLE DETECTOR SENSOR 1/4" DID NOT RESPOND TO AIR BUBBLES PASSAGE, NOT GENERATING AN ALARM AND CONSEQUENTLY NOT STOPPING THE PUMP. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

H10: MODEL AND SERIAL NUMBER OF THE INVOLVED BUBBLE SENSOR DETECTOR HAVE BEEN ADDED TO SECTION D OF THIS REPORT. COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO SIMILAR EVENT ON THIS DEVICE OCCURRED SINCE ITS INSTALLATION IN 2015. IT CANNOT BE RULED OUT THAT THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS A DEFECTIVE BUBBLE SENSOR AND CARDIOPLEGIA MODULE DUE TO WEAR. THE WEARING OF ELECTRO-MECHANICAL DEVICE CAN BE ORIGINATED BY THE SPECIFIC USE CONDITION AT CUSTOMER SITE AND MAY HAVE CONTRIBUTED TO THE EVENT.

Description of Event or Problem

SEE INITIAL REPORT.

Remedial action

  • Other