BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP 150 (S5 RP150)

    MDR report key: 19133049 · Received April 18, 2024

    Report

    Report Number
    9611109-2024-00186
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 16, 2024
    Report Date
    January 14, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WERE NOT PROVIDED. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ROLLER PUMP 150. THE INCIDENT OCCURRED IN FRANCE. LIVANOVA INTIATED AND INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    D.4 UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS NOT AVAILABLE FOR THIS PRODUCT AS IT IS A CLASS II MEDICAL DEVICE MANUFACTURED BEFORE SEPTEMBER 24, 2016 WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. H11: THE SERIAL READ-OUT (REAL TIME DEVICE PARAMETERS AND SETTING RECORDING FILE) OF THE INVOLVED PUMP WAS PROVIDED AND ANALYZED. FROM 10:53:02 TO 17:45:35 THE CAN CONTROLLER OF THE PUMP DETECTED MULTIPLE ERRORS ON THE SYSTEM BUS MOST LIKELY CAUSED BY COMPUTER BOARD (HKR). OVERSPEED ALARM AS REPORTED IN THE EVENT DESCRIPTION WAS NOT CONFIRMED. THE PUMP HAS BEEN REQUESTED FOR FURTHER INVESTIGATION AND REPAIR BUT WAS NEVER RETURNED. A DEVICE SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND IDENTIFIED THAT THE UNIT WAS MANUFACTURED IN 2009 AND NO OTHER SIMILAR EVENT HAS BEEN REPORTED, NEITHER CONCERNING TREND HAS BEEN IDENTIFIED. BASED ON THE ANALYSIS, THE ROOT CAUSE OF THE MULTIPLE PUMP STOPS CAN BE TRACED BACK TO THE CAN INTERRUPTION MOST LIKELY DUE TO THE FAULTY COMPUTER BOARD (HKR). AS PER EQUIPMENT MAINTENANCE INTERVENTIONS PREVENTION, THE HKR BOARD IS RECOMMENDED TO BE REPLACED.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED REPORT THAT A S5 ROLLER PUMP 150 PUMP MADE AN OVERSPEED ALARM DURIN PROCEDURE. SPECIFICALLY, AFTER 5 MINUTES OF CEC, THE ARTERIAL PUMP STOPPED FOR THE FIRST TIME AND RESTARTED BY ITSELF. THEN 30 SECONDS LATER THE ARTERIAL PUMP STOPPED AGAIN WITHOUT THE POSSIBILITY OF RESTARTING IT AND DISPLAYED ALARM: "ACCELERATION ERROR". MEDICAL TEAM, RESCUED THE PROCEDURE WITH EMERGENCY HAND CRANK, CHANGED THE ARTERIAL PUMP OUT AND RESUMED THE CEC. THE PATIENT EXPERIENCE HYPOTENSION FOR APPROXIMATELY 1 MINUTE. THERE IS NOT REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499221 S5 ROLLER PUMP 150 (S5 RP150) CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND GMBH 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown