FDA Adverse Event Malfunction Summary report: N

S5 ROLLER PUMP

MDR report key: 15518689 · Received September 30, 2022

Report

Report Number: 9611109-2022-00499
Event Type: Malfunction
Date Received: September 30, 2022
Date of Event: September 3, 2022
Report Date: February 15, 2023
Manufacturer: LIVANOVA DEUTSCHLAND
Product Code: DWB
UDI-DI: 04033817902713
PMA / PMN Number: K071318
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

PATIENT INFORMATION WAS NOT PROVIDED. LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN (B)(6). A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE PATIENT IS STILL IN THE ICU AND THAT A LOANER PUMP HAS BEEN PROVIDED IN REPLACEMENT OF THE CLAIMED ONE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 0

H.10. THE PUMP SHOWS ERROR CODE 442 WHICH MEANS THAT EITHER THE CURRENT MEASUREMENT ON HMF BOARD OR THE RESOLVER IS FAULTY (OR THE MOTOR IS BLOCKED). IN THIS CASE, THE OUTPUT SIGNALS FROM THE RESOLVER ARE NOT CORRECT AND THE HMS AND HMF BOARDS ARE CONFORMING. PUMP WILL BE REPAIRED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 0

H10: THE AFFECTED UNIT WAS RETURNED TO LIVANOVA DEUTSCHLAND FOR A DETAILED INVESTIGATION. THE INVESTIGATOR COULD REPRODUCE THE REPORTED ISSUE. IN ORDER TO FIX IT, PUMP HEAD (MOTOR) RP 150 AND MOTOR CONTROL BOARD WERE REPLACED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 0

LIVANOVA RECEIVED A REPORT STATING THAT DURING CPB PROCEDURE, MAIN ARTERIAL PUMP STOPPED. CUSTOMER TRIED TO SWITCH OFF AND ON AGAIN PUMP A COUPLE TIME WITHOUT SUCCESS AND HAND CRANK WAS PERFORMED. THE PATIENT CONDITION IS SEVERE. NO ADDITIONAL INFORMATION ON THE PATIENT'S STATUS WAS PROVIDED DUE TO DATA PROTECTION. THE REVIEW OF THE READ-OUT HIGHLIGHTED AND CONFIRMED THAT ERRORS RELATED TO THE MOTOR CONTROL FAILURE OCCURRED ON EVENT DATE. ADDITIONALLY, THE IMPACTED PUMP RETURNED FOR FURTHER INVESTIGATION AND TSI AT THE MANUFACTURING SITE. ERROR - FAULT IN MOTOR CONTROLLER (E431)- ALWAYS APPEARED WHEN THE PUMP WAS SWITCHED ON DURING INTERNAL TESTS. THUS, THE MOTOR CONTROL FAILURE HAS BEEN REPRODUCED. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. THE PUMP WAS MANUFACTURED IN JUNE 2021 AND THE ANALYSIS OF THE COMPLAINTS ON THIS PUMP HAS HIGHLIGHTED THAT NO OTHER EVENTS HAVE BEEN RECORDED BEFORE 3 SEPTEMBER 2022. THUS, THE EVENT IS ISOLATED. MOST LIKELY THE POWER SUPPLY OF THE IMPACTED HMS BOARD IS TURNED OFF, THE PUMP DOES NOT START THE DRIVE. IT CANNOT BE RULED OUT THAT A COMPONENT OF THE BOARD SUCH AS THE DC/DC CONVERTER (POWER SUPPLY) DID NOT WORK AND THIS LED TO THE ERRORS. BASED ON LIVANOVA MEDICAL TEAM, THE PATIENT OUTCOME IS RELATED TO THE PATIENT STATUS BEFORE THE PROCEDURE. THERE IS NO RELATIONSHIP BETWEEN PATIENT OUTCOME AND DEVICE FAILURE. THERE IS NO CONCERNING TREND FOR THIS KIND OF FAILURE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

Additional Manufacturer Narrative · 0

THE SERIAL READ OUT OF THE PUMP WAS PROVIDED AND ANALYSIS IS ONGOING. THROUGH FOLLOW-UP COMMUNICATION WITH THE PERFUSIONIST LIVANOVA LEARNED THAT: DURING PRIMING OF OXYGENATOR AND PRE-SETUP OF S5 HLM IT WAS NO ERROR MESSAGE DISPLAYED. IN BEGINNING OF CPB PROCEDURE, RIGHT AFTER CANNULATION, TEHRE WAS A MOTOR CONTROL FAILURE ERROR MESSAGE. PERFUSIONIST RESTARTED THE PUMP AND CLEARED THE ALARM AND THE PUMP WAS FUNCTIONING CORRECTLY. ON THE END OF CPB PROCEDURE THE PUMP STOPPED COMPLETELY AND TWO MOTOR CONTROL. FAILURE ERROR MESSAGES WERE DISPLAYED ATTEMPT TO RESTART THE PUMP WAS PERFORMED A COUPLE OF TIMES WITH NO IMPROVEMENT OF THE ISSUE. HAND CRANK WAS PERFORMED. CUSTOMER CHECKED PUMP FUNCTIONS A COUPLE OF TIMES IN NEXT DAY¿S (WITHOUT PATIENT CONNECTED) AND IN THE BEGINNING PUMP WORKED PROPERLY, BUT AFTER APPROXIMATELY 20 MINUTES - 1 HOUR PUMP STOPPED. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD NOT REPRODUCED THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.