S5 ROLLER PUMP

Additional Manufacturer Narrative

A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN OSAKA, JAPAN. THROUGH FOLLOW-UP COMMUNICATION IT WAS LEARNED THAT MOST LIKELY POTENTIAL EQUALIZATION CABLE IS NOT USED BY THE CUSTOMER. 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 A S5 ROLLER PUMP GAVE A MOTOR CONTROLLER ERROR MESSAGE (CODE 441) AND IT STARTED WORKING AGAIN WHEN THE MESSAGE WAS CLEARED. THE ISSUE OCCURRED DURING CLEANING, AFTER PROCEDURE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

H11: ACCORDING TO ADDITIONAL INFORMATION PROVIDED, NO HIGH FREQUENCY DEVICE WAS USED DURING THE PROCEDURE. EVENT LOG FILES OF INVOLVED S5 ROLLER PUMP PROVIDED BY CUSTOMER HAVE BEEN ANALYSED. THE ANALYSIS REVEALED THAT THE PUMP STORED SOFTWARE RESETS FOLLOWED BY THE CAN TIMEOUT ERROR (ERROR 441 REPORTED BY CUSTOMER). CAN TIMEOUT ERROR MESSAGE INDICATES THAT THE CONNECTION OF THE CAN BUS TO THE PUMP HAS BEEN TEMPORARY INTERRUPTED, AND THEREFORE THE PUMP COULD NOT BE CONTROLLED BY THE S5 SYSTEM. THE SOFTWARE RESET OF S5 DEVICES IS A DESIGNED PROTECTIVE FUNCTION OF THE SYSTEM: IF THE SYSTEM DETECTS AN EXCEPTION ON THE CAN BUS SIGNAL, IT PERFORMS A RESET TO PREVENT THE EXCEPTION TO PROPAGATE AND AFFECT SUBSYSTEMS FUNCTIONALITY. IF THE REBOOT IS DELAYED, THE TIMEOUT CAN BE DETECTED BY THE SYSTEM. POSSIBLE CAUSES FOR A DELAYED REBOOT ARE: - PERSISTENT INTERFERENCE ON THE CAN BUS; - WORN ELECTRONICS RELATED TO MULTIPLE AND NOT DETERMINISTIC FACTORS OVER TIME SUCH AS EXPOSURE TO HEAT, DUST AND MOISTURE, ACCIDENTAL IMPACTS (DROPS AND FALLS), AND POWER OVERLOADS/SURGES. THE SIGNAL ON THE CAN BUS CAN BE DISTORTED BY ELECTROMAGNETIC DISTURBANCES, FOR EXAMPLE IF THE SYSTEM IS NOT PROPERLY GROUNDED WITH THE MANDATORY POTENTIAL EQUALIZATION CABLE, BUT ALSO IN CASE OF MICROPROCESSOR FAILURE ON ELECTRONIC BOARDS. A LIVANOVA FIELD SERVICE TECHNICIAN ACTIVITY WAS CONDUCTED TO TEST INVOLVED ROLLER PUMP. THE DEVICE WAS USED AND CHECKED FOR A TIME PERIOD FROM 2 TO 3 WEEKS, AND NO ABNORMALITY NOR DEVIATION WAS FOUND UPON INTERNAL INSPECTION. BASED ON THE OVERALL ANALYSIS, ROOT CAUSE OF THE REPORTED EVENT IS MOST LIKELY DUE TO HIGH FREQUENCE INTERFERENCES IN THE OPERATING ROOM. IF A RESET OCCURS, THE PUMPS RESTART THEMSELVES AFTER FEW SECONDS, THEREFORE THE EVENT IS NOT LIKELY TO RESULT IN SERIOUS INJURY. THUS, THE REPORTED EVENT WAS RE-ASSESSED AS NOT REPORTABLE.

Description of Event or Problem

SEE INITIAL REPORT.