BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP 150 (S5 RP150)

    MDR report key: 15948565 · Received December 9, 2022

    Report

    Report Number
    9611109-2022-00659
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    August 29, 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

    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.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. LIVANOVA DEUTSCHLAND 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. LIVANOVA INITIATED AN INVESTIGATION IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP TURNED OFF DURING PROCEDURE. THE COMPLAINED PUMP IS NOT AN ARTERIAL PUMP. LATER, THE PUMP RESTARTED ON ITS OWN. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2886218 S5 ROLLER PUMP 150 (S5 RP150) CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown