BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE ROLLER PUMP 85

    MDR report key: 15948570 · Received December 9, 2022

    Report

    Report Number
    9611109-2022-00658
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    July 5, 2022
    Report Date
    November 11, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED.LIVANOVA (B)(4) MANUFACTURES THE S5 DOUBLE HEAD PUMP. THE INCIDENT OCCURRED IN AUSTRIA. THE ERROR COULD NOT BE VERIFIED BY THE BIOMEDICAL ENGINEERS IN THE HOSPITAL WHO DID THE REPAIR. THE HKR (COMPUTER BOARD) WAS REPLACED.THE READOUT OF THE HKR (COMPUTER BOARD) FROM THE LATEST CASE WAS PROVIDED TO LIVANOVA. THE LOG ONLY GOES BACK TO LATER THAN THE EVENT DATE.ACCORDING TO FOLLOW UP INFORMATION, THERE WAS NO ALARM OR ERROR CODE. THE PUMP WAS COMPLETELY DEACTIVATED AS IF POWER WAS SWITCHED OFF.IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H10: COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO SIMILAR EVENT ON THIS DEVICE OCCURRED SINCE ITS INSTALLATION IN 2008. MOST LIKELY ROOT CAUSE OF THE REPORTED ISSUE CAN BE TRACED BACK TO A DEFECTIVE COMPUTER BOARD (HKR) DUE TO THE WEARING OF ITS ELECTRONICS.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 DOUBLE ROLLER PUMP TURNED OFF DURING PROCEDURE IN WHICH IT WAS NOT USED AS ARTERIAL PUMP. LATER, THE PUMP RESTARTED ON ITS OWN. THERE IS NO 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
    2886223 S5 DOUBLE ROLLER PUMP 85 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown