BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP 5 (CP5)

    MDR report key: 7040057 · Received November 17, 2017

    Report

    Report Number
    9611109-2017-00912
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 14, 2017
    Report Date
    November 15, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K112225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP 5 (CP5). THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND REPLACED THE TOUCHSCREEN TO RESOLVE IT. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE WAS RETURNED TO SERVICE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. EVALUATED ON SITE BY LIVANOVA TECHNICIAN

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE TOUCHSCREEN OF THE CENTRIFUGAL PUMP 5 (CP5) BECAME UNRESPONSIVE DURING A PROCEDURE. THE PERFUSIONIST SWITCHED THE CP5 WITH ANOTHER ONE AND THE CASE WAS CONTINUED WITHOUT FURTHER ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822330 CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA LIVANOVA DEUTSCHLAND 60-02-60

    Patients

    Seq Age Sex Outcome Treatment
    1